NCT05835245

Cryoablation Combined With Sintilimab Plus Lenvatinib in 1L Treatment of Advanced ICC (CASTLE-ICC-Chemo-free)

A Phase II Study to Evaluate the Efficacy and Safety of Cryoablation Combined With Sintilimab Plus Lenvatinib as First-line Treatment in Patients With Unresectable Advanced Intrahepatic Cholangiocarcinoma (ICC)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (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 cryoablation combined with Sintilimab plus lenvatinib as first-line treatment in patients with advanced ICC.

Detailed description

Recent studies have suggested that local destruction of tumor tissue by cryoablation 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. And combination of pd-1 blocking antibody plus lenvatinib showed increased ORR in many types of human cancers. Therefore, the objective of this study is to evaluate the efficacy and safety of cryoablation combined with Sintilimab plus lenvatinib as first-line treatment in patients with advanced ICC.

Conditions

• Advanced Intrahepatic Cholangiocarcinoma

Interventions

Type	Name	Description
PROCEDURE	Cryoablation	Cryoablation is performed under US or CT guidance per Investigator decision.
DRUG	Sintilimab	a PD-1 immune check inhibitor
DRUG	Lenvatinib	Lenvatinib capsules

Timeline

• Start date: 2023-04-28
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2023-04-28
• Last updated: 2023-05-31

Locations

1 site across 1 country: China