drugset / Trial / NCT07229625

A Phase III Study of SHR-8068 in Combination With Adebrelimab and Platinum-Containing Chemotherapy Versus Durvalumab in Combination With Platinum-Containing Chemotherapy as First-line Treatment for Advanced Biliary Tract Cancer (BTC)

NCT07229625

Phase 3 Recruiting 604 enrolled Suzhou Suncadia Biopharmaceuticals Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is a randomized, open-label, multicenter phase III clinical trial, aiming to evaluate the efficacy and safety of SHR-8068 combined with adbelimab and platinum-based chemotherapy in contrast to varicumab combined with platinum-based chemotherapy in the first-line treatment of patients with advanced BTC.

Timeline

Start
2026-01-21
Primary completion
2029-12
Completion
2029-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Adebrelimab Monoclonal antibody
Comparator Durvalumab Monoclonal antibody
Subject SHR-8068 Monoclonal antibody
Background Cisplatin Other / unclassified
Background Gemcitabine Small molecule

Indications