Spots Global Cancer Trial Database for Cryoablation Combined With Sintilimab Plus Lenvatinib in Patients With Immune Checkpoint Inhibitor Previously Treated Advanced Biliary Tract Cancer （CASTLE-08）

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Trial Identification

Brief Title: Cryoablation Combined With Sintilimab Plus Lenvatinib in Patients With Immune Checkpoint Inhibitor Previously Treated Advanced Biliary Tract Cancer （CASTLE-08）

Official Title: A Phase II Study of Cryoablation Combined With Sintilimab Plus Lenvatinib in Patients With Immune Checkpoint Inhibitor Previously Treated Advanced Biliary Tract Cancer

Study ID: NCT05781074

Conditions

Advanced Biliary Tract Cancer

Interventions

Sintilimab

Lenvatinib

Cryoablation

Study Description

Brief Summary: The objective of this study is to evaluate the efficacy and safety of cryoablation combined with Sintilimab plus lenvatinib in patients with Immune Checkpoint Inhibitor previously treated advanced biliary tract cancer (BTC).

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 type of human cancers. Therefore, the objective of this study is to evaluate the efficacy and safety of cryoablation combined with Sintilimab plus lenvatinib in patients with Immune Checkpoint Inhibitor previously treated advanced BTC.