Clinical Trial

Study on Sequential Cryoablation, Relaforp Alpha, and Chemotherapy for Bile Duct Tumors

Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
This study is a prospective, multicenter, single-arm, open-label Phase II clinical trial, planned to enroll 30 patients with unresectable locally advanced or metastatic iCCA/GBC. Patients will first receive cryoablation treatment, and two weeks after ablation, they will receive 8 cycles of immunotherapy combined with chemotherapy (Relatlimab α plus GC chemotherapy, every 3 weeks). During the maintenance phase, patients will continue with Relatlimab α alone, every 3 weeks, for up to one year. During the combination treatment phase, efficacy will be evaluated every 6 weeks, and during the maintenance phase, every 6 to 9 weeks. From the date of randomization/enrollment, survival follow-ups will be conducted every 3 months (±14 days) for the first 2 years; afterwards, follow-ups will occur every 6 months (±28 days) until the participant dies, is lost to follow-up, or the study ends, whichever comes first.
Trial Details
NCT Number NCT07726446
Lead Sponsor Tianjin Medical University Cancer Institute and Hospital
Conditions Biliary Tract Cancer (BTC)
Enrollment 30 participants
Start Date 2026-10
Primary Completion 2027-10 (estimated)
Study Completion 2030-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-24