NCT04910386

Multicenter Phase 2 Study of Envafolimab in Biliary Tract Cancers

A Randomized, Open-Label, Multicenter Phase 2 Study 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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: 3D Medicines (Sichuan) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2027-06-01
• Primary completion: 2029-06-01
• Completion: 2029-12-01
• First posted: 2021-06-02
• Last updated: 2026-03-25