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Brief Title: Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC
Official Title: Gemcitabine and Oxaliplatin With or Without KN035 for Biliary Tract Cancer: a Randomised, Open-label, Parallel-group, Multicenter Phase III Study
Study ID: NCT03478488
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The Chinese people's liberation army (PLA) 81hospital, Nanjing, Jiangsu, China
Name: Shukui Qin
Affiliation: The Chinese people's liberation army (PLA) 81 hospital
Role: PRINCIPAL_INVESTIGATOR