RecruitingPhase 2NCT05057052

Cryoablation Combined with Sintilimab Plus Regorafenib in Previously Treated Colorectal Cancer Liver Metastasis

A Phase II Study of Cryoablation Combined with Sintilimab Plus Regorafenib in Previously Treated Colorectal Cancer Liver Metastasis (CASTLE-03)


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 Sintilimab plus regorafenib for patients with colorectal cancer liver metastasis in the third-line setting.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination approach for colorectal cancer that has spread to the liver, after other treatments have stopped working. The approach combines freezing the tumor (cryoablation) with two drugs: sintilimab (an immunotherapy) and regorafenib (a targeted therapy). **You may be eligible if...** - You have colorectal cancer that has spread to the liver - You have already tried at least two different chemotherapy regimens that stopped working - You are 18 or older and have reasonable overall health and organ function - You have at least one measurable tumor on imaging **You may NOT be eligible if...** - You have had previous cryoablation or regorafenib treatment - You had major surgery, radiation, or other liver procedures within the last 4 weeks - You have HIV, an active autoimmune disease, or require ongoing immunosuppressants - You have a history of stroke, blood clots, or significant heart disease in the past 6 months - You have a second active cancer 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 regorafenib will be initiated on day 14 after cryoablation. Sintilimab will be administered at 200 mg i.v. every 3 weeks.

DRUGRegorafenib

Regorafenib will be initiated on day 14 after cryoablation. Regorafenib 80 mg was given orally once daily on days 1-21 of a 28-day cycle 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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NCT05057052


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