NCT04954781

TACE Combined With Tislelizumab in Patients With Advanced Intrahepatic Cholangiocarcinoma

A Phase II Study of Transcatheter Arterial Chemoembolization (TACE) Combined With Tislelizumab in Patients With Advanced Intrahepatic Cholangiocarcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the efficacy and safety of TACE combined with Tislelizumab in patients with advanced intrahepatic cholangiocarcinoma after progression on first-line systemic therapy.

Detailed description

Transarterial chemoembolization (TACE) is commonly used for the treatment of advanced liver cancer. Recent studies have suggested that TACE induced activation and maturation of dendritic cells and tumor-specific T cells by cross-presentation of tumor antigens. While PD-1 blocking antibody interferes with PD-1 mediated T-cell regulatory signaling. Therefore, this study aims to evaluate the efficacy and safety of TACE combined with anti-PD-1 antibody in patients in advanced intrahepatic cholangiocarcinoma.

Conditions

• Intrahepatic Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	Tislelizumab	Tislelizumab will be initiated on day 14 after the first TACE session. Tislelizumab will be administered at 200 mg i.v. every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
COMBINATION_PRODUCT	TACE	TACE is performed by using drug-eluting beads. TACE treatment starts on day 0. The second TACE will be repeated on day 28 (± 5 days) if necessary per Investigator's decision.

Timeline

• Start date: 2021-07-14
• Primary completion: 2025-07-15
• Completion: 2025-07-15
• First posted: 2021-07-08
• Last updated: 2025-02-27

Locations

1 site across 1 country: China