Clinical Research Directory
Browse clinical research sites, groups, and studies.
Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC
Sponsor: 3D Medicines (Sichuan) Co., Ltd.
Summary
This is a randomized, open-label, parallel-group multi-center study of Phase 3 study to assess the efficacy and safety of KN035 compared to standard of care (SOC) Gemcitabine-based chemotherapies in the treatment of participants with previously untreated locally advanced or metastatic biliary tract cancer. The primary hypothesis of this study is that participants will have a longer overall Survival (OS) when treated with combined therapy than SOC.
Official title: Gemcitabine and Oxaliplatin With or Without KN035 for Biliary Tract Cancer: a Randomised, Open-label, Parallel-group, Multicenter Phase III Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
480
Start Date
2018-04-16
Completion Date
2026-12-31
Last Updated
2025-05-29
Healthy Volunteers
No
Conditions
Interventions
KN035 plus Gemcitabine & oxaliplatin
KN035 a programmed death ligand immune check inhibitor Per Investigator decision
Gemcitabine & oxaliplatin
The standard of care for the patients with unresectable/metastatic biliary tract cancer
Locations (1)
The Chinese people's liberation army (PLA) 81hospital
Nanjing, Jiangsu, China