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Organoid Drug Sensitivity-Guided Therapy for Refractory Tumors
Sponsor: Tianjin Medical University Second Hospital
Summary
This multicenter study will evaluate whether patient-derived tumor organoid drug sensitivity testing can help guide treatment selection for adults with refractory, unresectable, or metastatic tumors after standard treatment options have been exhausted. Fresh tumor tissue or malignant effusion will be collected when clinically obtained, and patient-derived organoids (PDOs) will be established and tested against clinically available drugs. Participants with successful organoid establishment and drug sensitivity results will receive treatment selected with reference to the test results and multidisciplinary clinical judgment. Tumor response will be assessed using RECIST version 1.1, with follow-up for progression, survival, and safety. The study plans nine tumor-specific cohorts.
Official title: A Multicenter, Multi-Arm, Exploratory Platform Clinical Study on the Therapeutic Efficacy of Organoid Drug Sensitivity-Guided Treatment in Patients With Refractory Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
144
Start Date
2025-10-01
Completion Date
2027-10-31
Last Updated
2026-10-30
Healthy Volunteers
No
Conditions
Interventions
Organoid drug sensitivity-guided treatment
Fresh tumor tissue or malignant effusion is collected for patient-derived organoid (PDO) culture. Drug sensitivity testing is performed on successfully established PDOs. The treatment regimen is then selected by investigators based on the drug sensitivity results, using approved agents within label indications or via MDT discussion. If organoid culture fails or the sensitivity result is negative, the regimen is selected based on clinical experience.
Locations (1)
Tianjin Medical University Second Hospital
Tianjin, Tianjin Municipality, China