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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University

About this trial

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 criteria

Qualifiers

Written informed consent obtained.

Age ≥ 18 years at time of study entry.

Participants must have unresectable liver metastasis from solid tumors.

Participants must have progressed after, or were refractory to first- or later-line therapy in the liver metastatic setting.

Disqualifiers

History of cardiac disease, including clinically significant gastrointestinal bleeding within 4 weeks prior to start of study treatment

Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months Prior to the first dose of study drug with the exception of thrombosis of a segmental portal vein.

Prior treatment with cryoablation.

RFA and resection administered less than 4 weeks prior to study treatment start.

Trial design

Treatments tested in this trial

  • Sintilimab
  • Lenvatinib
  • Cryoablation

Treatment groups

25 Participants
are divided into 1 treatment group

Sponsors and collaborators