PDO Based Drug Sensitive Test in R/M HNSCC
To evaluate the consistency of drug efficacy between the clinical systemic treatment and drug sensitive test based on patient-derived organoid in R/M HNSCC patients, using a prospective and multicenter observational study to increase the generalizability and reliability of research conclusion.
| Condition(s) | Head and Neck Squamous Cell Carcinoma, Patient Derived Organoid, Drug Sensitive Test in Vitro |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | To evaluate the consistency of drug efficacy between the clinical systemic treatment and drug sensitive test based on patient-derived organoid in R/M HNSCC patients, using a prospective and multicenter observational study to increase the generalizability and reliability of research conclusion. |
| Who can participate | Inclusion Criteria: * Pathologically confirmed R/M HNSCC patients * Tumor tissues available for organoid culture * ECOG score: 0-2 points * Life expectancy \> 3 months * Normal major organ function, tolerable to chemotherapy, targeted therapy, immunotherapy: a. Hematology examination criteria must meet: WBC≥4.0×109/L, ANC≥1.5×109/L, PLT≥80×109/L, Hb≥90 g/L (no blood transfusion or blood products within 14 days, no use of G-CSF or other hematopoietic growth factors); b. Biochemical examination must meet the following criteria: serum albumin≥3.0 g/dL (30 g/L), TBIL≤1.5×ULN, ALT, AST≤2.5×ULN, BUN and CRE≤1.5×ULN or endogenous creatinine clearance≥60 ml/min (Cockcroft-Gault formula); c. Good coagulation function: defined as International Normalized Ratio (INR) or Prothrombin Time (PT)≤1.5 time |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Huashan Hospital |
| Locations | Shanghai, Shanghai Municipality, China; Shanghai, Shanghai Municipality, China |
| Start date | 2025-03-26 |
| NCT ID | NCT06686342 |
| Official listing | https://clinicaltrials.gov/study/NCT06686342 |