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

NCT05098847 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-02-27

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Peng Wang, MD · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-29
Primary Completion
2025-10-30
Completion
2025-10-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05098847 on ClinicalTrials.gov