NCT04299581

Cryoablation Combined with Anti-PD-1 Antibody in Patients with Advanced Intrahepatic Cholangiocarcinoma

A Phase II Study of Cryoablation Combined with Anti-PD-1 Antibody （SHR-1210） 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 cryoablation combined with anti-pd-1 antibody in patients with advanced hepatocellular carcinoma after progression on first line systemic therapy.

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. Therefore, the objective of this study is to evaluate the efficacy and safety of cryoablation combined with anti-pd-1 antibody in patients in advanced intrahepatic cholangiocarcinoma.

Conditions

• Intrahepatic Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	Camrelizumab	a PD-1 immune check inhibitor
COMBINATION_PRODUCT	US/CT-guided Percutaneous Cryoablation	Cryoablation will be performed with a two-cycle freeze-thaw phase protocol; US or non-contrast CT images will be obtained to visualize the evolving ablation zone

Timeline

• Start date: 2020-07-07
• Primary completion: 2025-12-30
• Completion: 2026-12-30
• First posted: 2020-03-09
• Last updated: 2025-02-27

Locations

1 site across 1 country: China