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Cryoablation Combined With Sintilimab Plus Lenvatinib in Patients With Advanced Intrahepatic Cholangiocarcinoma

Intrahepatic Cholangiocarcinoma Clinical Trial

Official title:
A Phase II Study of Cryoablation Combined With Sintilimab Plus Lenvatinib in Patients With Advanced Intrahepatic Cholangiocarcinoma (CASTLE-01)

Clinical Trial Summary

The objective of this study is to evaluate the efficacy and safety of cryoablation combined with Sintilimab plus lenvatinib in patients with advanced intrahepatic Cholangiocarcinoma after progression on first line systemic therapy.

Clinical Trial 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 type of human cancers, including advanced intrahepatic cholangiocarcinoma. Therefore, the objective of this study is to evaluate the efficacy and safety of cryoablation combined with Sintilimab plus lenvatinib in patients with advanced intrahepatic cholangiocarcinoma. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05010668
Study type Interventional
Source Fudan University
Contact Peng Wang, MD
Phone 86-21-64175590
Email peng_wang@fudan.edu.cn
Status Recruiting
Phase Phase 2
Start date August 24, 2021
Completion date August 16, 2024
View Details
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