Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Biliary Tract Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Cisplatin

Antimetabolites

Envafolimab plus Gemcitabine\&Cisplatin Envafolimab: 300 mg on Day 1 of each cycle, subcutaneous injection. Every 21 days is a treatment cycle.

Gemcitabine (GEM): 1000 mg/m2 body surface area (BSA) administered on Days 1 and 8 of each cycle. Every 21 days is a treatment cycle with a maximum of 8 cycles.

Cisplatin (CIS): 25 mg/m2 body surface area (BSA) administered on Days 1 and 8 of each cycle. Every 21 days is a treatment cycle with a maximum of 8 cycles.

Gemcitabine (GEM): 1000 mg/m2 body surface area (BSA) administered on Days 1 and 8 of each cycle. Every 21 days is a treatment cycle with a maximum of 8 cycles.

Cisplatin (CIS): 25 mg/m2 body surface area (BSA) administered on Days 1 and 8 of each cycle. Every 21 days is a treatment cycle with a maximum of 8 cycles.

Envafolimab a programmed death ligand immune check inhibitor Per Investigator decision

Envafolimab plus Gemcitabine&Cisplatin

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

Gemcitabine&Cisplatin

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

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

To evaluate the progression-free survival (PFS) of envafolimab in combination with gemcitabine plus cisplatin (GemCis) versus first-line treatment of GemCis in patients with advanced biliary tract cancers (BTC).

To evaluate the overall survival (OS) of envafolimab in combination with GemCis versus GemCis in patients with advanced BTC;

To evaluate the objective response rate (assessed by the investigator per RECIST 1.1 criteria) of envafolimab in combination with GemCis versus GemCis in patients with advanced BTC;

To evaluate the duration of response (assessed by the investigator per RECIST 1.1 criteria) of envafolimab in combination with GemCis versus GemCis in patients with advanced BTC;

To evaluate the disease control rate (assessed by the investigator per RECIST 1.1 criteria) of envafolimab in combination with GemCis versus GemCis in patients with advanced BTC;

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Multicenter Phase 2 Study of Envafolimab in Biliary Tract Cancers	NCT04910386	Biliary Tract N...	Envafolimab plu... Gemcitabine&Cis...	18 Years -	3D Medicines
Multicenter Phase 2 Study of Envafolimab in Biliary Tract Cancers	NCT04910386	Biliary Tract N...	Envafolimab plu... Gemcitabine&Cis...	18 Years -	3D Medicines

Spots Global Cancer Trial Database for gemcitabine&cisplatin