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ACTIVE NOT RECRUITING
NCT03478488
PHASE3

Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC

Sponsor: 3D Medicines (Sichuan) Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

KN035 plus Gemcitabine & oxaliplatin

KN035 a programmed death ligand immune check inhibitor Per Investigator decision

DRUG

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