This is a prospective, non-randomized, open-label, single-center phase II clinical trial. It aims to evaluate the efficacy and feasibility of using patient-derived tumor organoid drug sensitivity testing (ODST) to guide personalized systemic therapy for patients with unresectable biliary tract cancers (BTC). A total of 88 eligible patients will be enrolled and grouped based on patient preference into either the ODST-guided group or the control group (standard therapy). Tumor tissues obtained via biopsy will be used to establish organoid cultures. Drug sensitivity testing will be performed on a panel of approved regimens (including GC, GEMOX, Durvalumab+GC, Pembrolizumab+GC, and Toripalimab+Lenvatinib+GEMOX) to identify the most effective treatment. Patients for whom organoid testing fails or results are unavailable within one month will receive standard therapy. The primary endpoints are Objective Response Rate (ORR) and Progression-Free Survival (PFS). Secondary endpoints include Overall Survival (OS) and safety profiles. The study seeks to provide a novel, personalized treatment strategy to improve outcomes for patients with advanced BTC.
Male or female, aged between 18 and 70 years (inclusive).
Diagnosis of biliary tract malignancy confirmed according to the NCCN Clinical Practice Guidelines.
The subject or their legal guardian understands and voluntarily signs the Informed Consent Form, and is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures as required by the protocol.
The subject is not a candidate for curative resection, transplantation, or local ablation therapy. This includes patients with recurrent disease after prior radical therapy who are not eligible for further curative resection or ablation.
Uncorrectable coagulopathy or individuals with a significant bleeding tendency.
Evidence of any concurrent malignant disease.
Diagnosis of another malignancy within 3 years prior to the first dose, except for radically treated cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and/or carcinoma in situ that has undergone curative resection.
Patients requiring long-term anticoagulant or antiplatelet therapy that cannot be discontinued.
Single group
Organoid Drug Sensitivity Testing-Guided Therapy
DrugFresh tumor tissue from resection is used to establish and culture patient-derived organoids. Successful organoids undergo drug sensitivity testing against a predefined panel of drugs (Gemcitabine + Cisplatin,Gemcitabine + Oxaliplatin,Durvalumab + Gemcitabine + Cisplatin,Pembrolizumab + Gemcitabine + Cisplatin,Toripalimab + Lenvatinib + Gemcitabine + Oxaliplatin). The most effective drug(s), based on IC50 and AUC values, are recommended for treatment
Objective Response Rate(ORR)
ORR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Progression-free Survival(PFS)
In treated subjects, the time from first recording to tumor progression (based on RECIST 1.1 and mRECIST) or death from any cause.
Overall Survival(OS)
Adverse event
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