Clinical trialNo phase (not a drug trial)Recruiting
Organoid Drug Sensitivity-Guided Therapy for Refractory Tumors
A Multicenter, Multi-Arm, Exploratory Platform Clinical Study on the Therapeutic Efficacy of Organoid Drug Sensitivity-Guided Treatment in Patients With Refractory Tumors
- Outcome
- Ongoing
- Phase
- No phase (not a drug trial)
- Status
- Recruiting
- Study type
- Interventional
- Start
- 1 October 2025
- Expected end
- 31 October 2027
- Enrollment
- 144 participants
- Sites
- 1
- Primary outcomes
- Objective Response Rate (ORR)
- Sponsor type
- Academic / other
- Results posted
- No
- Last update
- 30 October 2026
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
The study is designed to assess the clinical utility of PDO drug sensitivity testing in treatment selection for patients with refractory tumors. After consent and eligibility confirmation, fresh tumor tissue from biopsy or malignant effusion remaining after routine diagnostic needs will be used to establish PDOs. Organoids will undergo dose-response testing with marketed drugs used in clinical practice. Treatment decisions will be informed by the organoid sensitivity results and made by the treating clinicians; the protocol states that the drugs are guideline-recommended or may be considered after multidisciplinary discussion and that dosing will follow approved labeling. Participants will undergo routine imaging assessments and safety monitoring. If organoid culture fails or testing takes longer than 28 days, the participant is defined in the protocol as a removal/exclusion from subsequent study observation. The protocol describes nine tumor cohorts: non-small cell lung cancer, small cell lung cancer, prostate cancer, retroperitoneal leiomyosarcoma, colorectal cancer, gastric cancer, pancreatic cancer, bladder cancer, and non-clear cell renal cell carcinoma.