Organoid Drug Sensitivity-Guided Therapy for Refractory Tumors

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.

Inclusion Criteria: 1. Age 18 years or older; any sex. 2. Unresectable or metastatic disease with measurable lesions according to RECIST version 1.1; any number of prior lines of therapy. 3. Ability to obtain sufficient fresh tumor tissue or malignant effusion for organoid establishment before treatment. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 5. Estimated life expectancy of at least 6 months. 6. Willingness to participate, ability to comply with follow-up, and signed informed consent. Exclusion Criteria: 1. Pregnant or breastfeeding women. 2. Clinically significant active cardiac disease within the past 12 months, including congestive heart failure, symptomatic coronary artery disease, arrhythmia, or myocardial infarction. 3. Another malignancy within the past 5 years, except cured skin cancer. 4. Uncontrolled active bacterial, viral, fungal, mycobacterial, parasitic, or other infection within 4 weeks before enrollment, or a major systemic infection requiring intravenous antibiotics or hospitalization; tumor fever is excluded from this criterion. 5. Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.