NCT04191343

Clinical Study on the First-line Treatment of Advanced Biliary System Tumors With Tripley Monoclonal Antibody Combined With GEMOX Regimen

A Single-arm, Single-center, Prospective Clinical Study on the First-line Treatment of Advanced Biliary System Tumors With Tripley Monoclonal Antibody Combined With GEMOX Regimen

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open, single-arm, single-center, prospective phase II clinical study to evaluate the efficacy and safety of first-line tripletrumab combined with GEMOX chemotherapy in patients with advanced biliary tract tumors. Selected patients will receive the following treatment: Triplel monoclonal antibody (240mg, intravenous drip, d1, q3w);Combined with gemcitabine (1000mg/m2, intravenous drip, d1, d8, q3w) and oxaliplatin (100mg/m2, intravenous drip, d1, q3w) until the disease progresses or an intolerable adverse reaction occurs (the maximum treatment time is 2 years).

Conditions

• Advanced Biliary Tract Tumors

Interventions

Type	Name	Description
DRUG	Toripalimab injection combined with GEMOX	Toripalimab Injection (240mg, intravenous drip, d1, q3w);Combined with gemcitabine (1000mg/m2, intravenous drip, d1, d8, q3w) and oxaliplatin (100mg/m2, intravenous drip, d1, q3w)

Timeline

• Start date: 2019-10-14
• Primary completion: 2023-09-01
• Completion: 2024-06-01
• First posted: 2019-12-09
• Last updated: 2019-12-09

Locations

1 site across 1 country: China