RecruitingNCT06686342

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

Sponsor

Huashan Hospital

Enrollment

100 participants

Start Date

Mar 26, 2025

Study Type

OBSERVATIONAL

Conditions

Head and Neck Squamous Cell Carcinoma Patient Derived Organoid Drug Sensitive Test in Vitro

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study uses small lab-grown tumor models (called organoids or PDOs) grown from a patient's own tumor tissue to test which drugs work best for that individual — applied to people with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). **You may be eligible if...** - You have been confirmed to have recurrent or metastatic head and neck squamous cell carcinoma - Tumor tissue can be obtained for organoid culture - You are physically functional (ECOG 0–2) - Your life expectancy is more than 3 months - Your blood counts and organ function are within the required range **You may NOT be eligible if...** - Your head and neck cancer is not squamous cell carcinoma (e.g., sarcoma, nasopharyngeal cancer) - You are allergic to the study drugs or any monoclonal antibodies - You are pregnant or breastfeeding - You have active HIV, hepatitis B or C, or serious heart disease - You have a serious psychiatric illness or substance abuse history Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNo intervention

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.

OTHERNo Intervention: Observational Cohort

Locations(2)

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

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NCT06686342

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