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

PHASE2RecruitingINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

September 26, 2021

Primary Completion Date

September 25, 2026

Study Completion Date

September 25, 2026

Conditions
Liver MetastasesColorectal Cancer Metastatic
Interventions
DRUG

Sintilimab

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

DRUG

Regorafenib

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_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

Trial Locations (1)

200032

RECRUITING

Fudan University Shanghai Cancer Center, Shanghai

All Listed Sponsors
lead

Fudan University

OTHER