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A Randomized, Controlled, Multi-center Phase III Study of AK112 Combined With Gemcitabine Plus Cisplatin Versus Durvalumab Combined With Gemcitabine Plus Cisplatin as the First-line Treatment for Patients With Advanced Biliary Tract Cancer
This is a phase 3 study. All subjects are patients with unresectable locally advanced or metastatic biliary tract cancer (BTC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of AK112 in combination with chemotherapy versus durvalumab in combination with chemotherapy in patients with unresectable locally advanced or metastatic BTC.
Details
| Lead sponsor | Akeso |
|---|---|
| Phase | Phase 3 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 682 |
| Start date | 2024-10-20 |
| Completion | 2027-12 |
Conditions
- Biliary Tract Cancer
Interventions
- AK112, Gemcitabine, Cisplatin
- Durvalumab, Gemcitabine, Cisplatin
Primary outcomes
- Overall Survival (OS) — Up to approximately 2 years
OS is the time from randomization to death due to any cause.
Countries
China