RecruitingPhase 2NCT05098847

Cryoablation Combined with Sintilimab Plus Lenvatinib in Previously Treated Unresectable Liver Metastasis from Solid Tumors

A Phase II Study of Cryoablation Combined with Sintilimab Plus Lenvatinib in Previously Treated Unresectable Liver Metastasis from Solid Tumors (CASTLE-04)


Sponsor

Fudan University

Enrollment

25 participants

Start Date

Oct 29, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The objective of this study is to evaluate the efficacy and safety of cryoablation combined with Sintilimab plus lenvatinib for patients with unresectable liver metastasis, who had progressed after, or were refractory to first- or later-line therapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination approach for people with cancer that has spread to the liver: using cryoablation (freezing the tumor) alongside two drugs — sintilimab (an immunotherapy) and lenvatinib (a targeted therapy) — to shrink or destroy liver tumors. **You may be eligible if...** - You have any solid tumor that has spread to the liver and cannot be surgically removed - Your liver metastases have progressed after at least one prior treatment - You have at least one measurable tumor in the liver - You are reasonably active (ECOG performance status 2 or better) - Your expected survival is at least 12 weeks - Your blood counts and organ function meet the required minimums **You may NOT be eligible if...** - You have active uncontrolled infections - Your organ function is too poor to tolerate treatment - 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

DRUGSintilimab

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

DRUGLenvatinib

Sintilimab plus lenvatinib will be initiated on day 14 after cryoablation. Lenvatinib (bodyweight ≥ 60 kg, 12 mg; \< 60 kg, 8 mg) was given orally daily every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

DRUGCryoablation

Cryoablation treatment starts at day 0. 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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NCT05098847


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