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Multicenter Phase 2 Study of Envafolimab in Biliary Tract Cancers

NCT04910386 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2026-03-25

No results posted yet for this study

Summary

This is a Randomized, Open-Label, Multicenter Phase 2 Study to access the efficacy and safety of Envafolimab in Combination with Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin as the First-line Treatment in Patients with Locally Advanced or Metastatic Biliary Tract Cancers

Conditions

  • Biliary Tract Neoplasms

Interventions

DRUG

Envafolimab plus Gemcitabine&Cisplatin

Envafolimab a programmed death ligand immune check inhibitor Per Investigator decision

DRUG

Gemcitabine&Cisplatin

The standard of care for the patients with unresectable/metastatic biliary tract cancer

Sponsors & Collaborators

  • 3D Medicines (Sichuan) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-06-01
Primary Completion
2029-06-30
Completion
2029-12-31

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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 NCT04910386 on ClinicalTrials.gov