NCT05738057

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

Combined Therapy Using D-TACE, Gemcitabine and Cisplatin Chemotherapy, and PD1 Antibody for Patients With Advanced and Unresectable Intrahepatic Cholangiocarcinoma: a Single-center, Single-arm Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Hua Li · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Unresectable Intrahepatic Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	Camrelizumab	200mg on day1 of every 3 weeks, starting on day1 of cycle1
DRUG	Gemcitabine Injection	1000mg/m2 on day1 \& day8 of every 3 weeks, starting on day1 of cycle 1
DRUG	Cisplatin injection	25mg/m2 on day1 \& day8 of every 3 weeks, starting on day1 of cycle 1
DRUG	Cisplatin-Eluting Beads	used for D-TACE
PROCEDURE	D-TACE	TACE with Cisplatin-Eluting Beads (with Cis 30mg). More TACE can be done if clinically necessary.

Timeline

• Start date: 2023-06-30
• Primary completion: 2025-03-01
• Completion: 2026-03-01
• First posted: 2023-02-21
• Last updated: 2023-11-29

Locations

1 site across 1 country: China