PDO Based Drug Sensitive Test in R/M HNSCC
Consistency Evaluation of Drug Efficacy Between Clinical Systemic Treatment and Drug Sensitive Test Based on Patient-derived Organoid in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma: A Prospective, Multicenter, Observational Study
Huashan Hospital
100 participants
Mar 26, 2025
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 times ULN; if the study participant is on anticoagulant therapy, as long as PT is within the intended range of the anticoagulant medication
- Able to understand the content of informed consent form, sign the informed consent form, and willing to cooperate with the follow-up
Exclusion Criteria9
- Metastatic tumors in the head and neck region, or non-HNSCC such as sarcoma, adenocarcinoma, nasopharyngeal carcinoma, etc.
- Known allergy to the study drugs or their active ingredients or any excipients; or had a severe allergic reaction to other monoclonal antibodies
- Pregnant or breastfeeding female patients; or women of childbearing age with positive pregnancy test results (serum or urine) within 7 days before enrollment, or negative results but refusing to use effective contraception during the study period and 2 months after the last administration of study medication; or male patients with partners of childbearing age, refusing to use effective contraception during the study period and 2 months after the last administration of study medication
- Severe liver diseases (such as cirrhosis), kidney diseases, respiratory system diseases, hematopoietic system diseases, or endocrine system diseases, uncontrolled diseases
- Infected with HIV, active hepatitis B (HBV-DNA≥104 copies/ml) or hepatitis C (hepatitis C antibody positive, and HCR-RNA above the lower limit of detection of the analytical method), uncontrolled diseases
- Within 6 months before enrollment, the following conditions occurred: myocardial infarction, severe/unstable angina, NYHA class 2 or above heart failure, clinically significant supraventricular or ventricular arrhythmias, and symptomatic congestive heart failure, uncontrolled diseases
- Patients with mental illness or known history of psychiatric drug abuse or drug addiction
- Unable to give consent, unable to obtain the required amount of tumor tissue for the study
- Other serious physical or mental diseases or laboratory test abnormalities that may increase the risk of participating in the study or interfere with the study results; or any other situation that the researchers deem unsuitable for participation in this study
Interventions
The patients with R/M HNSCC would receive drug treatment according to the clinical guideline or doctor's experience, at the same time, tumor biopsy samples would be collected to establish PDO for drug sensitive test. But no intervention would be used based on the PDO drug sensitive test.
The patients with R/M HNSCC would receive drug treatment according to the clinical guideline or doctor's experience, at the same time, tumor biopsy samples would be collected to establish PDO for drug sensitive test. But no intervention would be used based on the PDO drug sensitive test.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06686342