Lenvatinib Plus Sintilimab in Patients With Immune Checkpoint Inhibitor Previously Treated Advanced Liver Cancer

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 Lenvatinib plus Sintilimab in patients with advanced liver cancer progressed after treatment with immune checkpoint inhibitors.

Eligibility criteria

Qualifiers

Written informed consent obtained.

Age ≥ 18 years at time of study entry.

Participants must have unresectable or metastatic histologically or cytologically confirmed hepatocellular carcinoma or intrahepatic cholangiocarcinoma

Participants must have disease progression with an anti-PD-1 or anti-PD-L1 based regimen.

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 Lenvatinib or other targeted therapy.

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

Trial design

Treatments tested in this trial

  • Sintilimab
  • Lenvatinib

Treatment groups

25 Participants
are divided into 1 treatment group

Sponsors and collaborators