A Phase II Trial of Organoid Drug Sensitivity Testing to Guide Therapy in Unresectable Biliary Tr… (NCT07351591) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Phase II Trial of Organoid Drug Sensitivity Testing to Guide Therapy in Unresectable Biliary Tract Cancers
88 participantsStarted 2026-01-30
Plain-language summary
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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Life expectancy of at least 12 weeks.
. No radiotherapy within 12 weeks prior to the first dose of the study drug.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses something called 'organoid drug sensitivity testing' to guide which treatment I'd receive — can you explain how growing a mini-tumor from my tissue would actually change the chemotherapy or targeted therapy I'd be given compared to the standard approach?
2Since this is a Phase II trial, what do we know so far about the safety and effectiveness of letting organoid testing drive treatment decisions for biliary tract cancer, and are there risks I should be aware of that wouldn't exist with standard care?
3The trial is listed as 'not yet recruiting' — do you know roughly when it's expected to open, and given how quickly advanced biliary tract cancer can progress, should we be starting a standard treatment now rather than waiting to see if I'd be eligible?
4The trial is measuring objective response rate and progression-free survival — can you help me understand what those outcomes actually mean for my day-to-day life, and how the results might compare to what standard first-line treatment for unresectable biliary tract cancer typically achieves?
5Since this trial requires tumor tissue to grow organoids, would I need a new biopsy if my existing tissue samples aren't suitable, and how does that additional procedure fit with my current condition and overall treatment timeline?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Liver function classified as Child-Pugh Class A or Class B with a score of 7.
. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Exclusion criteria
. 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.
. Presence of hepatic encephalopathy or refractory pleural effusion/ascites requiring therapeutic intervention.
. Other anti-tumor or systemic therapies within 2 weeks prior to enrollment:
. History of systemic treatment for active autoimmune disease or ongoing immunosuppressive therapy: