drugset / Trial / NCT05738057

Combined Therapy Using D-TACE, Gemcitabine and Cisplatin, and PD1 Antibody in Advanced and Unresectable Intrahepatic Cholangiocarcinoma

NCT05738057 ↗

Phase 2 Unknown 22 enrolled Hua Li
NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to learn about the combined therapy using drug-eluting bead-transarterial chemoembolization (D-TACE), gemcitabine (Gem) and cisplatin (Cis) chemotherapy, and PD-1 antibody in patients with advanced and unresectable intrahepatic cholangiocarcinoma (ICC). The main questions it aims to answer are: * Whether combined therapy using D-TACE, Gem/Cis, and PD-1 works well to convert unresectable ICC to resectable. * Whether combined therapy using D-TACE, Gem/Cis, and PD-1 is safe. Participants will receive D-TACE (CalliSpheres with Gem 30 mg), camrelizumab (200 mg) plus gemcitabine (1000 mg/m2) and cisplatin (25 mg/m2), and 24 months follow-up.

Timeline

Start
2023-06-30
Primary completion
2025-03-01
Completion
2026-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Camrelizumab Monoclonal antibody 200 mg Intravenous
Subject Cisplatin Other / unclassified 25 mg/m2 Intravenous
Subject Cisplatin Other / unclassified 30 mg Intravenous
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous