Patient-derived organoid drug sensitivity testing for recurrent/metastatic head and neck cancer

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

This project will test whether drug-sensitivity results from a patient's tumor-derived organoids predict which systemic treatments work best for people with recurrent or metastatic head and neck cancer.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Huashan Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 2 sites (Shanghai, Shanghai Municipality and 1 other locations)
• Trial ID: NCT06686342 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter observational study enrolling patients with recurrent or metastatic head and neck squamous cell carcinoma who can provide tumor tissue for organoid culture. Tumor samples are grown into patient-derived organoids and subjected to high-throughput in vitro drug sensitivity testing, and those results are compared with the patient's real-world systemic treatment choices and clinical outcomes. The multicenter design across major Shanghai cancer centers aims to improve the generalizability and reliability of concordance estimates. No experimental treatment is assigned; clinical care follows standard practice.

Who should consider this trial

Good fit: Ideal participants are adults with pathologically confirmed recurrent or metastatic HNSCC who can provide tumor tissue for organoid culture, have ECOG 0–2, sufficient organ function, a life expectancy over three months, and can give informed consent.

Not a fit: Patients without available tumor tissue, with poor organ function or ECOG >2, a very limited life expectancy, or who cannot travel to participating centers are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, organoid-based testing could help doctors select more effective systemic drugs for individual patients and avoid ineffective therapies.

How similar studies have performed: Organoid-based drug sensitivity testing has shown high predictive accuracy in gastrointestinal cancers in prior studies, but it remains less well validated specifically for recurrent/metastatic head and neck cancer.

Eligibility criteria

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 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 Criteria:

* 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

Where this trial is running

Shanghai, Shanghai Municipality and 1 other locations

• Huashan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (Active_not_recruiting)
• Huashan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Lai-ping Zhong, MD, PhD — Huashan Hospital
• Study coordinator: Lai-ping Zhong, MD, PhD

Conditions Head and Neck Squamous Cell Carcinoma; Patient Derived Organoid; Drug Sensitive Test in Vitro; Recurrent/metastatic head and neck squamous cell carcinoma; Patient-derived organoid; Drug sensitive test in vitro