NCT05057845

Cryoablation Combined with Tislelizumab Plus Lenvatinib As Second-line or Later Therapy in Advanced Hepatocellular Carcinoma

A Phase II Study of Cryoablation Combined with Tislelizumab Plus Lenvatinib As Second-line or Later Therapy in Patients with Advanced Hepatocellular Carcinoma (CASTLE-02)

• 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 Tislelizumab plus lenvatinib as second-line or later therapy in patients with advanced hepatocellular carcinoma.

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, including advanced hepatocellular carcinoma. Therefore, the objective of this study is to evaluate the efficacy and safety of cryoablation combined with Tislelizumab plus lenvatinib as second-line or later therapy in patients with advanced hepatocellular carcinoma.

Conditions

• Advanced Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Tislelizumab	Tislelizumab will be initiated on day 14 after cryoablation. Tislelizumab will be administered at 200 mg i.v. every 3 weeks
DRUG	lenvatinib	Lenvatinib will be initiated on day 14 after cryoablation. Lenvatinib will be administered (bodyweight ≥ 60 kg, 12 mg; \< 60 kg, 8 mg) orally daily every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
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: 2021-09-26
• Primary completion: 2026-09-20
• Completion: 2026-09-20
• First posted: 2021-09-27
• Last updated: 2025-02-27

Locations

1 site across 1 country: China