NCT05781074

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

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

• Status: Unknown
• 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 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.

Conditions

• Advanced Biliary Tract Cancer

Interventions

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

Timeline

• Start date: 2023-03-23
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2023-03-23
• Last updated: 2023-03-24

Locations

1 site across 1 country: China