NCT05406466

Cryoablation Combined With Tislelizumab Plus Lenvatinib in Patients With Melanoma Liver Metastasis

A Phase II Study of Cryoablation Combined With Tislelizumab Plus Lenvatinib in Patients With Melanoma Liver Metastasis (CASTLE-05)

• 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 Tislelizumab plus lenvatinib in patients with melanoma liver metastasis.

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 Tislelizumab plus lenvatinib in patients with melanoma liver metastasis.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Tislelizumab	a PD-1 immune check inhibitor
DRUG	Lenvatinib	multitargeted receptor tyrosine kinase inhibitor
DRUG	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: 2022-07-15
• Primary completion: 2024-07-10
• Completion: 2024-08-16
• First posted: 2022-06-06
• Last updated: 2022-11-10

Locations

1 site across 1 country: China