Health Trials

A Platform Trial for Personalized and Adaptive Therapies in Hepatocellular Carcinoma

ConditionHepato Cellular Carcinoma (HCC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University

About this trial

This is a phase II, multi-arm, Bayesian adaptive platform trial designed to efficiently evaluate novel therapies for advanced hepatocellular carcinoma (HCC) after first-line treatment failure. The study aims to rapidly identify the most effective investigational regimens and discover predictive biomarker signatures (from tumor tissue, blood, and imaging) to guide personalized second-line therapy.

Eligibility criteria

Qualifiers

Written informed consent obtained.

Age ≥ 18 years at time of study entry.

Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/ cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic patients.

Patients who have previously received first-line therapy with anti-PD-1/PD-L1 combined with anti-VEGF antibodies, or anti-PD-1/PD-L1 combined with TKI, or anti-PD-1/PD-L1 combined with anti-CTLA-4 antibodies and experienced disease progression; or disease recurrence within 6 months after completion of neoadjuvant/adjuvant immunotherapy.

Disqualifiers

Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.

Patients on a liver transplantation list or with advanced liver disease.

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.

Trial design

Treatments tested in this trial

  • Lenvatinib
  • Regorafenib (BAY 73-4506)
  • Tislelizumab+TKI
  • HAIC+TKI
  • HAIC + Tislelizumab+TKI
  • QL1706+TKI
  • HAIC + QL1706+TKI
  • TUDCA + Camrelizumab+TKI
  • XELOX + QL1706+TKI
  • XELOX + Tislelizumab+TKI

Treatment groups

350 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Sponsors and collaborators

Fudan University

Lead sponsor

Source ClinicalTrials.gov