NCT04595929NARecruiting
St. Petersburg State Pavlov Medical University · First Pavlov State Medical University of St. Petersburg, Saint Petersburg
Stomach cancer is recognized as the third leading cause of death of cancer patients worldwide. Despite the radical treatment carried out, the progression of gastric cancer occurs in 30-40% of patients. The most common type of tumor progression of this localization is peritoneal carcinomatosis. When peritoneal carcinomatosis occurs, the median survival of patients does not exceed 3 months, the overall survival is no more than 6 months. Unfortunately, when peritoneal carcinomatosis occurs, palliative chemotherapy remains the only treatment option. The modern strategy for the prevention and treatment of peritoneal carcinomatosis is based on the concept of regional chemotherapy. The main methods of regional chemotherapy are hyperthermic intraperitoneal chemotherapy (HIPEC) and Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC). PIPAC is a new technology for delivering chemotherapy drugs to tumor nodes on the surface of the peritoneum and allows the cytostatic to be evenly distributed over the abdominal cavity, increasing the depth of its penetration into tumor nodes due to the properties of aerosol and gradients of intra-abdominal and interstitial pressure. The method has a number of advantages over the HIPEC method: a large penetration depth of drugs, low trauma, the possibility of repeated use. We offer PIPAC for patients with locally advanced gastric cancer and a high risk of developing peritoneal carcinomatosis in an adjuvant mode in addition to standard treatment to prevent the development of carcinomatosis.
Eligibility: 18 Years to 65 Years · All · * Histologically confirmed, medically operable, resectable stomach adenocarcinoma (cT3-4, any N category, M0).
* No preceding cytotoxic or targeted therapy.
* No prior partial or complete tumor resection.
* Female and male patient ≥ 18 and ≤ 75 years. Female patient with childbearing potential needs to have a negative pregnancy test within 7 days prior to study start. Males and females of reproductive potential must agree to practice highly effective contraceptive measures\* during the study. Male patients must also agree to refrain from father a child during treatment and additionally to use a condom during treatment period. Their female partner of childbearing potential must also agree to use an adequate contraceptive measure.
\*highly effective (i.e. failure rate of \<1% per year when used consistently and correctly) methods: intravaginal and transdermal combined (estrogen and progestogen containing) hormonal contraception; injectable and implantable progestogen-only hormonal contraception; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence (complete abstinence is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments).
* ECOG = 0-2.
* Exclusion of distant metastases by CT or MRI of abdomen, pelvis, and thorax, bone scan or MRI (if bone metastases are suspected due to clinical signs). Exclusion of the infiltration of any adjacent organs or structures by CT or MRI.
* Laparoscopic exclusion of peritoneal carcinomatosis at initial staging, before start of FLOT chemotherapy
* Adequate hematological, hepatic and renal function parameters:
Leukocytes ≥ 3000/mm³, platelets ≥ 100,000/mm³, neutrophil count (ANC) ≥1000/µL Serum creatinine ≤ 1.5 x upper limit of normal Bilirubin ≤ 1.5 x upper limit of normal, AST and ALT ≤ 3.0 x upper limit of normal, alkaline phosphatase ≤ 6 x upper limit of normal For patients not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 x ULN; for patients receiving therapeutic anticoagulation: stable anticoagulant regimen.
* Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures.
NCT07331883Phase 2Recruiting
Ruijin Hospital · Sanming First Hospital, Sanming, Fujian
Primary liver cancer-particularly hepatocellular carcinoma (HCC)-remains a major health burden in China, characterized by high incidence and mortality rates and poor 5-year survival. Spontaneous rupture of HCC (SRHCC), although a relatively uncommon complication, is associated with extremely high mortality and marked geographic variation, with disproportionately higher incidence and rupture-related deaths reported in Asian populations. For patients with preserved liver function and resectable tumors, hepatic resection can offer favorable long-term survival and even a potential cure. However, despite surgical removal, the risk of postoperative recurrence is substantially increased, and long-term outcomes remain unsatisfactory. Currently, there is no validated adjuvant therapy to reduce recurrence or improve survival after resection.
In recent years, immune checkpoint inhibitors (ICIs) in combination with anti-angiogenic agents have demonstrated synergistic antitumor activity and manageable safety in advanced HCC. Notably, studies of sintilimab plus a bevacizumab biosimilar have shown significant improvements in overall survival (OS), progression-free survival (PFS), and objective response rate (ORR). Moreover, emerging evidence in the adjuvant and perioperative settings suggests that PD-1 blockade may delay recurrence in high-risk patients, such as those with microvascular invasion.
Based on the high postoperative recurrence rate in SRHCC patients and the existing therapeutic gap, along with established evidence of the efficacy of immune checkpoint inhibitors combined with antiangiogenic therapy in advanced HCC, conducting a prospective Phase II single-arm study of adjuvant therapy with sintilimab plus the bevacizumab biosimilar holds significant clinical and scientific value. This study aims to evaluate the tolerability of this combination regimen in postoperative SRHCC patients at high risk of recurrence. It is expected to provide a more effective treatment option for patients diagnosed with spontaneously ruptured hepatocellular carcinoma, improve their prognosis, and offer scientific evidence for future treatment strategies.
Eligibility: 18 Years to 75 Years · All · * Patients voluntarily provide written informed consent, with authorization obtained from the patient or legal representative prior to any protocol-related procedures.
* Age ≥ 18 years and ≤ 75 years; both female and male
* Spontaneous tumor rupture with hemorrhage confirmed by imaging prior to or during surgery, with a postoperative pathological diagnosis of hepatocellular carcinoma (HCC).
a) For cases where tumor rupture is an incidental finding during surgery, a clinical history of abdominal pain within the two weeks preceding surgery is required.
* CNLC Stage I-II.
* Having undergone curative surgical resection, with intraoperative irrigation using ≥5000 mL of distilled water or normal saline, confirmed negative surgical margins on postoperative pathology, and achieving a complete response (CR) confirmed by imaging within 4-8 weeks after surgery.
* ECOG PS 0-1
* Child-Pugh A (score ≤6).
* Life expectancy ≥12 months
* Laboratory test results obtained within 3 days prior to the first dose must meet the following criteria:
1. Hematological:(Except for hemoglobin, the patient must not have received a blood transfusion, granulocyte colony-stimulating factor \[G-CSF\], or hematopoietic agents within 2 weeks prior to screening.) i. Absolute neutrophil count ≥1.5 × 10⁹/L; ii. Platelet count ≥75 × 10⁹/L; iii. Hemoglobin ≥90 g/L.
2. Serum biochemistry:
i. Serum albumin ≥30 g/L; ii. Total bilirubin ≤1.5 × ULN; iii. ALT and AST ≤3 × ULN; iv. Serum creatinine ≤1.5 × ULN, or creatinine clearance \>50 mL/min.
3. International normalized ratio (INR) ≤1.2 or prothrombin time (PT) ≤2 seconds above the upper limit of normal.
4. Urinalysis:Urine protein \<2+.(If urine protein is ≥2+, a 24-hour urine protein test may be performed; patients may be enrolled if 24-hour urine protein \<1.0 g.)
* For patients with HBV infection (i.e., HBsAg-positive), HBV DNA must be tested. HBV DNA levels must be \<2000 IU/mL (or \<10⁴ copies/mL if the study site reports results in copies/mL). Patients with HBV DNA ≥2000 IU/mL must receive at least 1 week of antiviral therapy prior to the first dose, using only nucleos(t)ide analogues such as entecavir, tenofovir disoproxil fumarate, or tenofovir alafenamide. HBV DNA levels must show a ≥1-log (10-fold) reduction before initiation of study treatment. All HBV-infected patients must continue antiviral therapy throughout the entire study period. Patients who are HCV RNA-positive must receive antiviral treatment according to current clinical guidelines.
* Female patients of childbearing potential must have a negative β-hCG pregnancy test prior to the first dose. Female patients of childbearing potential and male patients with partners of childbearing potential must agree to use effective contraception during treatment and for 6 months after the last dose of study medication.
NCT07305337NARecruiting
Zhongnan Hospital · Zhongnan Hospital of Wuhan University, Wuhan, Hubei
With the rapid advancement of biopharmaceutical technology, clinical trials have become the crucial bridge connecting new drugs from the laboratory to clinical application. Despite the increasing number of clinical trial projects being conducted, nearly all such projects face the common challenge of recruitment difficulties. Subject recruitment constitutes a pivotal stage in clinical trials; the ability to recruit a sufficient number of subjects meeting the trial requirements significantly impacts trial quality and also serves as a key factor influencing trial progress. Hematologic cancers constitute a highly heterogeneous group of malignant diseases originating in the haematopoietic organs and primarily affecting the haematopoietic system. They encompass acute and chronic leukaemias, malignant lymphomas, multiple myeloma, myelodysplastic syndromes, and related disorders. For patients facing treatment decisions, clinical trials represent not only a vital avenue for accessing cutting-edge therapies but also impose heightened demands on their capacity for informed decision-making. Conversational artificial intelligence (AI) based on large language models is rapidly advancing in health education and public health communication. Medical chatbots offer scalable and personalised advantages in delivering health information, promoting behavioural change, and enhancing patient engagement, providing a viable pathway for improving trial literacy and decision support. Accordingly, this study proposes to conduct a clinical trial literacy intervention using AI-powered chatbots among haematological malignancy patients. Through a randomised controlled trial (RCT), it aims to evaluate the impact of AI-assisted health education on patients' understanding of clinical trials and intention to participate. This research seeks to validate the application value of AI technology in health education and explore scalable AI-assisted health education intervention models.
Eligibility: 18 Years to 90 Years · All · Inclusion Criteria (1) Aged ≥18 years with clear consciousness; (2) Diagnosed with haematological malignancy meeting clinical treatment criteria (WHO criteria); (3) Capable of understanding health education content and possessing basic communication skills; (4) Willing to participate in this study and sign an informed consent form.
Exclusion Criteria
(1) Patients with concomitant cognitive impairment, psychiatric disorders, or other conditions severely affecting comprehension; (2) Anticipated hospital stay of less than 3 days, rendering completion of the intervention unfeasible; (3) End-of-life palliative care; (4) Previous participation in other clinical trial education programmes.
NCT07590310EARLY_Phase 1Recruiting
Peking University Cancer Hospital & Institute · Peking University Cancer Hospital, Beijing, Haidian
According to the 2020 global cancer statistics, renal carcinoma ranks as the fourteenth most common malignant tumor worldwide. In 2020, there were 431,288 new cases and 179,368 deaths from renal cancer, and both the incidence and mortality rates are projected to continue rising by 2025. Early non-invasive diagnosis of clear cell renal cell carcinoma (ccRCC) is crucial for improving prognosis. Nuclear medicine molecular imaging offers the advantages of real-time, dynamic, and non-invasive detection of lesions throughout the body. However, there is currently a lack of highly efficient and targeted molecular probes for early and accurate diagnosis of this tumor in clinical practice.
The high expression of CAIX plays a central role in the pathogenesis of renal cancer by altering cellular metabolism, inducing angiogenesis, promoting epithelial-mesenchymal transition (EMT), invasion, and metastatic spread. CAIX is highly expressed in 95% of ccRCC cases. In fact, CAIX expression levels have been reported as an independent predictor of survival in advanced ccRCC. Moreover, CAIX expression in normal tissues is limited, primarily restricted to the stomach, the basolateral aspects of proliferating small intestinal crypt epithelial cells, and the gallbladder. Therefore, the differential expression of CAIX between ccRCC tumors and normal tissues highlights its potential as a robust target for nuclear medicine molecular probe research and development in ccRCC.
This study utilized high-throughput screening to identify small molecules with high affinity for CAIX. These molecules were subsequently cyclized and modified to enhance their in vivo stability. A bifunctional chelator, H3RESCA, was introduced at the C-terminus to construct the small-molecule compound RESCA-CAIX-LT. PET probes were prepared by radiolabeling with 68Ga or 18F, and their diagnostic efficacy for renal cancer was investigated. Small-animal PET imaging initially demonstrated that the probe exhibits high affinity and excellent imaging performance. The modifications also altered the in vivo metabolic profile of the original design, reducing non-specific uptake in organs such as the stomach, small intestine, and gallbladder. Furthermore, toxicological experiments confirmed the probe's high safety profile and in vivo stability.
Eligibility: 18 Years to 75 Years · All · -Hematological, hepatic, and renal functions meeting the following criteria: Complete Blood Count: WBC ≥4.0×10⁹/L or Neutrophils ≥1.5×10⁹/L, PLT ≥100×10⁹/L, Hb ≥90 g/L; Coagulation: PT or APTT ≤1.5 × ULN (Upper Limit of Normal); Hepatic Function: T-Bil ≤1.5 × ULN; ALT/AST ≤2.5 × ULN (or ≤5 × ULN for subjects with liver metastases); ALP ≤2.5 × ULN (or ≤4.5 × ULN for subjects with bone or liver metastases); Renal Function: BUN ≤1.5 × ULN, SCr ≤1.5 × ULN.
Normal cardiac function;
* Expected survival ≥12 weeks;
* Good compliance with follow-up;
* At least one measurable target lesion according to RECIST 1.1 criteria;
* Women of childbearing potential (aged 18-49) must have a negative pregnancy test within 7 days prior to the examination. Male and female patients of childbearing potential must agree to use effective contraception to prevent pregnancy during the study and for 3 months after the examination;
* Patients for whom the clinician recommends a PET/CT examination for tumor diagnosis and staging;
* Patients are fully capable of understanding the study, voluntarily agree to participate, and provide written informed consent.
NCT06364956Phase 1, Phase 2Recruiting
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong
In order to explore the safety and antitumor efficacy of different doses of CDK4/6 inhibitor Palbociclib in combination with the Tislelizumab in platinum-refractory cT2-4aN0M0 bladder urothelial carcinoma, a phase Ib/II study was conducted.
This study will adopt a 3+3 design and include two predefined dose groups of palbociclib: 100mg QD, 125mg QD. Initially, Tislelizumab, 200 mg administered by intravenous infusion on Day 1 of each 21-day will be administered in combination. The trial will use the first cycle (28 days) as the observation period for tolerability, observing and evaluating the occurrence of DLTs after medication and determining the maximum tolerated dose/maximum administered dose (MTD/MAD) and recommended phase 2 dose (RP2D) of the combination therapy (30 patients) .
This study provide further evidence for improving the efficacy of neoadjuvant treatment forplatinum-refractory cT2-4aN0M0 bladder urothelial carcinoma and to offer new options for precision treatment of bladder cancer.
Eligibility: 18 Years to · All · 1. Voluntarily participate in this study, able to provide written informed consent and can understand and agree to comply with the requirements of the study and schedule of assessments.
2. Aged over 18 years on day of signing informed consent
3. Patients with urothelial bladder cancer, having residual lesions following TURBT surgery, staged cT2-T4aN0M0 as histologically confirmed and radiologically assessed based on the TNM Staging System for Bladder Cancer of American Joint Committee on Cancers (AJCC) ; predominantly histological classification of urothelial carcinoma (at least 50%) for patients with mixed-histology bladder cancer.
4. Patients with mutations or copy number variation (CNV) alterations, such as CDKN2A, CDKN2B CNV deletion, indicating the activation of cell cycle-related pathways.
5. ECOG Performance Status 0 or 1
6. Ineligible for Cisplatin treatment as judged by investigator. Patients who are ineligible for Cisplatin chemotherapy should meet at least one of the following criteria: ECOG performance status \> 1 or Karnofsky performance status 60% to 70%; creatinine clearance less than 60 mL/min; ≥ Grade 2 hearing loss according to NCI-CTCAE v5.0; ≥ Grade 2 neuropathy peripheral according to NCI-CTCAE v5.0; ≥ Grade 3 cardiac failure according to New York Heart Association Cardiac Function Classification
7. Patients will receive radical cystectomy following neoadjuvant therapy as assessed by investigator, meet surgical indication and are willing to receive the surgery.
8. Tumor tissue samples collected during TURBT must be available, and relevant pathological reports are required. Fresh surgical tissue samples or pathological slides are optional
9. Have adequate organ function as indicated by the following screening laboratory values (obtained ≤ 14 days prior to enrollment):
a.Patients must not be administered with growth factors ≤ 14 days prior to sampling for the screening tests of: i.Absolute neutrophil count ≥ 1.5 x 109/L ii.Platelets ≥ 90 x 109/L iii.Hemoglobin ≥ 90 g/L b.International normalized ratio or activated partial thromboplastin time ≤ 1.5 x upper limit of normal (ULN).
c.Serum total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN, if Gilbert's syndrome or if indirect bilirubin concentrations were suggestive of extrahepatic source of the elevation).
e.Aspartate transaminase (AST), alanine aminotransferase (ALT), and alkaline phosphatase ≤ 2.5 x ULN f.Patients can tolerate major abdominal surgery as suggested by pulmonary function test results
10. Unpregnant females or females of childbearing potential must be willing to use a highly effective contraceptive method for the duration of the study, and ≥ 120 days after the last dose of Tislelizumab or chemotherapy agents, whichever is later, and have a negative urine or serum pregnancy test ≤ 7 days prior to enrollment.
NCT07322263Phase 2Recruiting
Michael A. O'Donnell · University of Iowa, Iowa City, Iowa
The goal of this clinical trial is to learn whether a combination of two chemotherapy drugs, Gemcitabine and Docetaxel, can treat high-grade non-muscle-invasive bladder cancer (HG-NMIBC) in adults whose cancer failed conventional BCG therapy. The drugs are given directly into the bladder (intravesically), one immediately after the other.
The study will also assess the safety of this treatment.
The main questions it aims to answer are:
Can this drug combination effectively treat HG-NMIBC that did not respond to BCG and help prevent the cancer from coming back, offering long-term protection? What side effects or medical issues do participants experience during treatment?
Researchers will evaluate this non-surgical approach as a potential alternative to bladder removal surgery (radical cystectomy), with the goal of validating it as a bladder-sparing option in this setting.
Participants will:
* Go through a screening process, including tumor removal and imaging tests
* Receive weekly bladder treatments with Gemcitabine followed by Docetaxel for 6 weeks
* If the cancer responds, continue with similar once monthly treatments (maintenance therapy) for up to 2 years
* Attend regular check-ups, including bladder exams, urine tests, biopsies, and optional quality-of-life surveys
* Possibly receive a second 6-week treatment cycle if the cancer returns early
* Be followed for up to 5 years to monitor long-term outcomes
Eligibility: 18 Years to 99 Years · All · Histologically confirmed diagnosis of urothelial carcinoma of the bladder without synchronous or metachronous upper tract involvement or prostatic urethral involvement. Subjects with negative upper tract imaging within 6 months of the study start and visually normal prostates are potentially eligible. Those with a history of suspicious upper tract cytology or suspicious prostatic urethra visually will require additional upper tract washes and/or biopsies to rule out concurrent extravesical disease.
Eligible bladder cancer presentations include:
* Carcinoma in situ (CIS), with or without non-muscle-invasive stage Ta or T1 tumors of any grade.
* High-Grade Papillary tumors (stages Ta and/or T1) without CIS.
* All visible bladder tumors must be completely resected within 8 weeks prior to initiating intravesical Gem/Doce therapy.
* If more than 8 weeks have passed since diagnosis or resection of index bladder CIS ± non-invasive tumor (pTa or T1 tumors), an office cystoscopy must be performed within 8 weeks of Gem/Doce initiation to confirm no visible tumor regrowth.
BCG-Unresponsive Disease as defined by any of the following FDA-accepted criteria:
* Occurrence of high-grade, stage T1 cancer after at least 5/6 weekly BCG induction treatments.
* Occurrence of CIS within 12 months, or high-grade papillary disease, stage Ta/T1, within 6 months after an "adequate" course of BCG therapy.
An "adequate" course of BCG includes at least 5/6 weekly BCG induction treatments and at least 2/3 weekly BCG maintenance or 2/6 weekly BCG re-induction treatments.
* N.B: Physician may have some flexibility (+/- 1 month) in the use of 6 and 12 months to define BCG-unresponsive NMIBC.
* N.B: Once a patient has been correctly defined as having BCG-unresponsive disease, they will be considered to always be BCG-unresponsive for the purpose of this study. In other words, there is no restriction as to when the BCG-unresponsive term was assigned.
* The occurrence of low-grade (LG) Ta disease will not be considered a HG relapse event given its prognosis is much more favorable that HG disease. However, all LG tumor must be completely resected before continuing with Gemcitabine/Docetaxel therapy.
* Subjects must be eligible for radical cystectomy and decline this standard of care treatment or not be a surgical candidate for radical cystectomy (as appropriate) based on other comorbidities.
* All grossly visible disease in the bladder must be fully resected with pathologic stage and grade assessed at the local study institution. Local pathologists are strongly encouraged to use the current LG and HG AJCC criteria.
NB: For institutions that still use the 3-tiered grading system, Ta Gr1 and Gr 2 will be considered LG while any Ta Gr3 or T1 Gr2 or Gr3 will be considered HG.
* Patients enrolled in other clinical trials must have received their last treatment at least 8 weeks prior to enrollment if the treatment was an intravesical agent. If the treatment included a systemic immune-modulating agent (e.g. anti-PD(L)-1 or anti CTLA4) then at least two dosing intervals must have elapsed untreated before the patient is eligible.
* Age \> 18 and must be able to read, understand and sign the local informed consent.
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance Status of 2 or less, including patients who are not surgical candidates due to comorbid conditions.
* Women of childbearing potential must have a negative pregnancy test at screening.
* All patients of childbearing potential must be willing to consent to using effective contraception, i.e., IUD, Birth control pills, Depo-Provera, and/or condoms while on treatment and for 3 months after their last Gemcitabine/Docetaxel treatment.
* No intravesical or upper tract topical therapy within 8 weeks of study entry.
* Must be willing and able to comply with all protocol requirements.
* Should have a Complete Blood Count (CBC) with differential before the index tumor resection or bi
NCT06524973NARecruiting
City of Hope Medical Center · City of Hope at Arcadia, Arcadia, California
This clinical trial evaluates the impact of telehealth self-management coaching sessions on quality of life in pancreatic cancer survivors and their family care givers (FCGs). Patients with pancreatic cancer experience many symptoms because of the disease and treatment, which can have a negative impact on quality of life. Patients and their families have unmet needs during treatment, including a lack of quality of life programs that offer support to patients. Supporting patients and families on managing the physical symptoms, emotional well-being, social well-being and spiritual well-being with telehealth self-management coaching sessions may help improve quality of life, manage symptoms from treatment, and support families in their role as caregivers during treatment.
Eligibility: 18 Years to · All · * • PATIENT: Documented informed consent of the participant and/or legally authorized representative
* Assent, when appropriate, will be obtained per institutional guidelines
* PATIENT: Age: ≥ 18 years
* PATIENT: Eastern Cooperative Oncology Group (ECOG) ≤ 2
* PATIENT: Ability to read and understand English or Spanish for questionnaires
* PATIENT: Subjects must have histologically or cytologically confirmed diagnosis of metastatic pancreatic adenocarcinoma who are within 8 weeks of initial diagnosis
* FAMILY CARE GIVER: Documented informed consent of the participant and/or legally authorized representative
* Assent, when appropriate, will be obtained per institutional guidelines
* FAMILY CARE GIVER: Age: ≥ 18 years
* FAMILY CARE GIVER: Ability to read and understand English or Spanish for questionnaires
* FAMILY CARE GIVER: A family member or friend identified by the patient and defined as a person who knows the patient well and is involved in the patient's medical care
NCT07305337NARecruiting
Zhongnan Hospital · Zhongnan Hospital of Wuhan University, Wuhan, Hubei
With the rapid advancement of biopharmaceutical technology, clinical trials have become the crucial bridge connecting new drugs from the laboratory to clinical application. Despite the increasing number of clinical trial projects being conducted, nearly all such projects face the common challenge of recruitment difficulties. Subject recruitment constitutes a pivotal stage in clinical trials; the ability to recruit a sufficient number of subjects meeting the trial requirements significantly impacts trial quality and also serves as a key factor influencing trial progress. Hematologic cancers constitute a highly heterogeneous group of malignant diseases originating in the haematopoietic organs and primarily affecting the haematopoietic system. They encompass acute and chronic leukaemias, malignant lymphomas, multiple myeloma, myelodysplastic syndromes, and related disorders. For patients facing treatment decisions, clinical trials represent not only a vital avenue for accessing cutting-edge therapies but also impose heightened demands on their capacity for informed decision-making. Conversational artificial intelligence (AI) based on large language models is rapidly advancing in health education and public health communication. Medical chatbots offer scalable and personalised advantages in delivering health information, promoting behavioural change, and enhancing patient engagement, providing a viable pathway for improving trial literacy and decision support. Accordingly, this study proposes to conduct a clinical trial literacy intervention using AI-powered chatbots among haematological malignancy patients. Through a randomised controlled trial (RCT), it aims to evaluate the impact of AI-assisted health education on patients' understanding of clinical trials and intention to participate. This research seeks to validate the application value of AI technology in health education and explore scalable AI-assisted health education intervention models.
Eligibility: 18 Years to 90 Years · All · Inclusion Criteria (1) Aged ≥18 years with clear consciousness; (2) Diagnosed with haematological malignancy meeting clinical treatment criteria (WHO criteria); (3) Capable of understanding health education content and possessing basic communication skills; (4) Willing to participate in this study and sign an informed consent form.
Exclusion Criteria
(1) Patients with concomitant cognitive impairment, psychiatric disorders, or other conditions severely affecting comprehension; (2) Anticipated hospital stay of less than 3 days, rendering completion of the intervention unfeasible; (3) End-of-life palliative care; (4) Previous participation in other clinical trial education programmes.
NCT07305337NARecruiting
Zhongnan Hospital · Zhongnan Hospital of Wuhan University, Wuhan, Hubei
With the rapid advancement of biopharmaceutical technology, clinical trials have become the crucial bridge connecting new drugs from the laboratory to clinical application. Despite the increasing number of clinical trial projects being conducted, nearly all such projects face the common challenge of recruitment difficulties. Subject recruitment constitutes a pivotal stage in clinical trials; the ability to recruit a sufficient number of subjects meeting the trial requirements significantly impacts trial quality and also serves as a key factor influencing trial progress. Hematologic cancers constitute a highly heterogeneous group of malignant diseases originating in the haematopoietic organs and primarily affecting the haematopoietic system. They encompass acute and chronic leukaemias, malignant lymphomas, multiple myeloma, myelodysplastic syndromes, and related disorders. For patients facing treatment decisions, clinical trials represent not only a vital avenue for accessing cutting-edge therapies but also impose heightened demands on their capacity for informed decision-making. Conversational artificial intelligence (AI) based on large language models is rapidly advancing in health education and public health communication. Medical chatbots offer scalable and personalised advantages in delivering health information, promoting behavioural change, and enhancing patient engagement, providing a viable pathway for improving trial literacy and decision support. Accordingly, this study proposes to conduct a clinical trial literacy intervention using AI-powered chatbots among haematological malignancy patients. Through a randomised controlled trial (RCT), it aims to evaluate the impact of AI-assisted health education on patients' understanding of clinical trials and intention to participate. This research seeks to validate the application value of AI technology in health education and explore scalable AI-assisted health education intervention models.
Eligibility: 18 Years to 90 Years · All · Inclusion Criteria (1) Aged ≥18 years with clear consciousness; (2) Diagnosed with haematological malignancy meeting clinical treatment criteria (WHO criteria); (3) Capable of understanding health education content and possessing basic communication skills; (4) Willing to participate in this study and sign an informed consent form.
Exclusion Criteria
(1) Patients with concomitant cognitive impairment, psychiatric disorders, or other conditions severely affecting comprehension; (2) Anticipated hospital stay of less than 3 days, rendering completion of the intervention unfeasible; (3) End-of-life palliative care; (4) Previous participation in other clinical trial education programmes.
NCT04872166Phase 1Recruiting
Edgewood Oncology Inc. · Florida Cancer Specialists, Lake Mary, Florida
This is a multicenter, open label, nonrandomized, sequential dose escalation/dose ranging, multiple dose study designed to evaluate the safety, toxicity, and PK as well as preliminary efficacy of BTX-A51 alone and in combination with fulvestrant in subjects with advanced solid tumors. The study will be done in three phases, described below.
Phase 1a (Dose Escalation Phase):
The Phase 1a portion is designed to determine the dose limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of orally administered BTX-A51. BTX-A51 will be administered once daily on a weekly schedule of 5 days on/2 days off. Dose escalation will proceed according to a modified 3+3 design. Each cycle will consist of 28 days (4 weeks), and the DLT observation period will be the first cycle (i.e., 28 days after initiation of dosing). A DLT may be observed in no more than 0 out of 3 or 1 out of 6 subjects who have completed the DLT observation period before the next cohort initiates accrual. Barring DLT, sequential dose escalation of BTX-A51 is planned with up to a total of 6 dose levels; on the basis of these an MTD will be identified. The MTD is defined as the highest dose level with a subject incidence of DLTs of 0 or 1 out of 6 during the first 28 days of study drug dosing. A minimum of 6 subjects needs to be treated at a dose level before this dose level can be deemed as the MTD.
Phase 1b (Monotherapy Dose Ranging Phase):
Dose expansion may begin when the RP2D has been determined. Up to 40 additional subjects at each of the 2 dose levels will be enrolled to evaluate safety and preliminary efficacy of BTX-A51 in subjects with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), GATA3 mutant (mt) and wild-type (wt) metastatic breast cancer (mBC). Dosing in this phase of the study consists of the first cycle of therapy (i.e., 28 days).
Phase 1c (Combination Safety Phase):
The Phase 1c portion will evaluate the safety and tolerability of orally administered BTX-A51 at two dose levels combined with fulvestrant. The first combo cohort may be initiated after DEC review of the 6 subject lead-in phase of the high dose monotherapy cohort in Phase 1b. Dose escalation will proceed according to a 3+3 design. Each cycle will consist of 28 days (4 weeks), and the DLT observation period will be the first cycle (i.e., 28 days after initiation of dosing).
Eligibility: 18 Years to · All · * Demonstration of understanding and voluntarily signing of an informed consent form
* Age ≥ 18 years
* Histologically or cytologically documented, incurable or metastatic solid tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available
* Phase 1b and 1c only: Histologically confirmed diagnosis of ER+, HER2- mBC not amenable to resection or radiation therapy with curative intent.
* Measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
* Adequate organ function
* Females of childbearing age must not be pregnant at time of Screening/beginning of treatment and agree to either abstain from sexual intercourse or use highly effective methods of contraception (for up to 3 months after last dose of study drug)
* Males sexually active with a woman of childbearing age must agree to use barrier method of birth control during and after the study (up to 3 months after last dose of study drug)
