Exploratory Study of Precise Therapy for Advanced Tumor Patients With Malignant Hydrothorax or Ascites by Using PTC Drug Sensitivity Testing
NCT06413212 · Phase II · Wuhan, Hubei, China
- Condition
- Stomach Cancer
- Disease stage
- Stage I-IV
- Phase
- Phase II
- Study type
- DIAGNOSTIC_TEST
- Intervention
- Patient-derived tumor-like cell clusters (PTC) drug sensitivity testing.
- Age
- 18 Years to
- Gender
- All
- Sponsor
- Liu Huang
- Research institution
- Liu Huang
- Facility
- Tongji Hospital
- Research center
- Tongji Hospital
Summary
To explore the consistency between result of PTC drug screening tests and actual clinical outcome for patients with advanced malignancy.
Detailed description
This study is anticipated to enroll 55 patients with advanced malignancy, and fresh malignant effusion samples collected from patients would be detected by PTC drug screening. In addition, patients would receive 2 cycles of personal therapy based on results of screening tests. By combining PTC drug sensitivity results with patient's treatment process and clinical feedback, researchers may evaluate the sensitiveness and specificity of PTC drug screening technique in predicting clinical outcome for advanced malignancy patients.
Inclusion criteria
1. 18 to 75 years old, regardless of gender. 2. Score of nutrition risk screening 2002 (NRS2002) is less than 3, NRS20023. 3. Advanced and unresectable malignancy confirmed by biopsy diagnosis. 4. Able to tolerate anti-tumor treatment, and without serious cardiopulmonary and other underlying diseases. 5. Score of eastern cooperative oncology group (ECOG) is not higher than 2, ECOG≤2. 6. Anticipated survival exceed six months. 7. At least one measurable lesions (according to RECIST 1.1) 8. Resistance or intolerance to standard therapy regimens. 9. Signed informed consent form voluntarily.
Exclusion criteria
1. Pregnant or lactating women. 2. Have Participated other clinical trials in six months. 3. Severe liver dysfunction. 4. Severe renal dysfunction. 5. Patients with cognitive disorder, mental diseases and terrible compliance. 6. Allergic to known chemotherapeutic agents. 7. Other circumstance not suitable to participate in this trial determined by investigators.
Primary outcomes
Complete Response (CR); Partial Response (PR); Progressive Disease (PD)