Clinical Research Directory
Browse clinical research sites, groups, and studies.
AK112 Combined With Chemotherapy Versus Durvalumab Combined With Chemotherapy in Advanced Biliary Tract Cancer
Sponsor: Akeso
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
682
Start Date
2024-10-20
Completion Date
2027-12
Last Updated
2026-01-21
Healthy Volunteers
No
Conditions
Interventions
AK112, Gemcitabine, Cisplatin
AK112 will be administered at a selected dose intravenously (IV) every three weeks (Q3W). Gemcitabine will be administered at 1000 mg/m2, D1, D8, Q3W, intravenously (IV) for 8 cycles. Cisplatin will be administered at 25 mg/m2, D1, D8, Q3W, intravenously (IV) for 8 cycles.
Durvalumab, Gemcitabine, Cisplatin
Durvalumab will be administered at 1500mg intravenously (IV) every three weeks (Q3W) for 8 cycles and followed by monotherapy every 4 weeks. Gemcitabine will be administered at 1000 mg/m2, D1, D8, Q3W, intravenously (IV) for 8 cycles. Cisplatin will be administered at 25 mg/m2, D1, D8, Q3W, intravenously (IV) for 8 cycles.
Locations (2)
Harbin Medical University Cancer Hospital
Harbin, China
Zhongshan Hospital, Fudan University
Shanghai, China