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

PHASE2RecruitingINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

October 29, 2021

Primary Completion Date

October 30, 2025

Study Completion Date

October 30, 2025

Conditions
Liver Metastasis
Interventions
DRUG

Sintilimab

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

DRUG

Lenvatinib

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.

DRUG

Cryoablation

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

Trial Locations (1)

200032

RECRUITING

Fudan University Shanghai Cancer Center, Shanghai

All Listed Sponsors
lead

Fudan University

OTHER