drugset
drugset / Trial / NCT04191343

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

NCT04191343 ↗

Phase 2 Unknown 20 enrolled Zhejiang Cancer Hospital
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2019-10-14
Primary completion
2023-09
Completion
2024-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Toripalimab Monoclonal antibody 240 mg Intravenous
Background Gemcitabine Small molecule 1000 mg/m2 Intravenous
Background Oxaliplatin Small molecule 100 mg/m2 Intravenous

Indications

biliary tract cancer