Phase Ib/II Multicenter Randomized Control Study of Peri-operative Treatment With Combination of CTLA-4, PD-1 Antibodies and Bevacizumab in Resectable HCC (Prophet)

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Zhongshan Hospital

About this trial

The purpose of this phase Ib/II multicenter randomized control study is to investigate the efficacy and safety of peri-operative treatment with combination of CTLA-4, PD-1 antibodies and bevacizumab in resectable HCC

Eligibility criteria

Qualifiers

Written informed consent shall be obtained prior to any trial-related procedures.

Male or female patients aged ≥18 years and ≤75 years.

Initial resectable hepatocellular carcinoma (HCC) confirmed by imaging, pathology or cytology.

No macrovascular tumor thrombus or extrahepatic metastasis detected on imaging examinations.

Disqualifiers

Histologically or cytologically confirmed tumors containing components of fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, or other mixed subtypes.

History of hepatic encephalopathy or prior liver transplantation.

Currently participating in an interventional clinical trial, or received any investigational medicinal product or investigational device within 4 weeks prior to the first study drug administration.

Prior receipt of any of the following therapies: anti-PD-1, anti-PD-L1, anti-PD-L2 agents, or agents targeting other T-cell co-stimulatory or co-inhibitory receptors (including but not limited to CTLA-4, OX-40, CD137).

Trial design

Treatments tested in this trial

  • IBI310+ sintilimab + bevacizumab
  • IBI310+ sintilimab
  • sintilimab + bevacizumab

Treatment groups

90 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators