Cryoablation Combined with Tislelizumab Plus Lenvatinib As Second-line or Later Therapy in Advanced Hepatocellular Carcinoma
NCT05057845 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2025-02-27
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.
Conditions
Interventions
- 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 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
Sponsors & Collaborators
-
Fudan University
lead OTHER
Principal Investigators
-
Peng Wang, MD · Fudan University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-09-26
- Primary Completion
- 2026-09-20
- Completion
- 2026-09-20
Countries
- China
Study Locations
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