Phase 3 Study BGB-A317 Vs Sorafenib in Patients with Unresectable HCC
Research type
Research Study
Full title
A Randomized, Open-label, Multicenter Phase 3 Study to Compare the Efficacy and Safety of BGB-A317 versus Sorafenib as First-Line Treatment in Patients with Unresectable Hepatocellular Carcinoma
IRAS ID
237285
Contact name
Timothy Meyer
Contact email
Sponsor organisation
BeiGene, Ltd. c/o BeiGene USA, Inc
Eudract number
2017-002423-19
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 5 months, 0 days
Research summary
This is a multi-centre, open-label Phase III study in participants with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. Eligible participants will be randomised to receive either BGB-A317 or sorafenib.
BGB-A317 is a monoclonal antibody acting on PD-1. A monoclonal antibody is a type of protein made in the laboratory which can be “programmed” to bind to specific substances in the body or on cells, like cancer cells. PD-1, called programmed cell death -1, is a protein present on the surface of immune cells. After binding to its ligand, PD-1 can inhibit the killing of tumour cells by immune cells. BGB-A317 can act on PD-1, thereby eliminating its inhibitory effect on the immune cells, so that immune cells can attack tumour cells.
Sorafenib belongs to a group of medicines call tyrosine kinase inhibitors that is approved in the UK to treat participants with unresectable HCC.
All participants will receive study treatment until intolerable toxicity, withdrawal of informed consent, or the time point at which the participant, in the opinion of the investigator, is no longer benefiting from study therapy. Participants will be followed for survival and subsequent anticancer therapies.
This study is taking place in the UK and other countries. The Sponsor of the study is BeiGene, Ltd. c/o BeiGene USA, Inc. Around 640 participants are expected to be involved in the trial.REC name
London - City & East Research Ethics Committee
REC reference
18/LO/0855
Date of REC Opinion
24 Aug 2018
REC opinion
Further Information Favourable Opinion