MedTrace Logo

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

NCT03478488 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2025-05-29

No results posted yet for this study

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.

Conditions

  • Biliary Tract Neoplasms

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

Sponsors & Collaborators

  • 3D Medicines (Sichuan) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Shukui Qin · The Chinese people's liberation army (PLA) 81 hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-16
Primary Completion
2024-09-10
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03478488 on ClinicalTrials.gov