RecruitingPhase 2NCT05057845

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)


Sponsor

Fudan University

Enrollment

25 participants

Start Date

Sep 26, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study combines freezing the tumor (cryoablation) with two drugs — tislelizumab (an immunotherapy) and lenvatinib (a targeted therapy) — as a second-line or later treatment for advanced liver cancer (hepatocellular carcinoma) that cannot be surgically removed. **You may be eligible if...** - You have advanced liver cancer (hepatocellular carcinoma) confirmed by biopsy or imaging - Your cancer has progressed or become intolerable on at least one prior treatment regimen - You are 18 or older with adequate organ function and reasonable overall health - You have at least one measurable tumor **You may NOT be eligible if...** - You have not tried any prior systemic treatment for advanced liver cancer - You have severe active autoimmune disease or are on immunosuppressants - You have uncontrolled infections, HIV, or certain other serious conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTislelizumab

Tislelizumab will be initiated on day 14 after cryoablation. Tislelizumab will be administered at 200 mg i.v. every 3 weeks

DRUGlenvatinib

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_PRODUCTUS/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


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT05057845


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