NCT07836530Not yet recruitingPhase 3
Study Comparing BGB-B2033 With Sorafenib or Lenvatinib in Relapsed Hepatocellular Carcinoma
A Randomized, Open-Label, Phase 3 Study to Investigate the Efficacy and Safety of BGB-B2033 Compared With Investigator Choice of Sorafenib or Lenvatinib in Patients With Hepatocellular Carcinoma That Progressed Upon Prior Systemic Treatment
Source: ClinicalTrials.gov · Last updated 23 Sept 2026
Brief summary (registry, in English)
The goal of this clinical trial is to learn how well BGB-B2033 works and how safe it is in people with hepatocellular carcinoma (HCC) who have previously received up to two treatments that included programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) medicines. Researchers will compare BGB-B2033 with either sorafenib or lenvatinib chosen by the study doctor to see which treatment works better and is safer. The main questions it aims to answer are: * Does BGB-B2033 help control or slow the growth of liver cancer? * What medical problems or side effects do participants have while taking BGB-B2033? * Does BGB-B2033 help to prolong the survival for liver cancer participants over Lenvatinib/sorafenib?
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 492 (estimated)
- First submitted
- 17 Sept 2026
- Start date
- Oct 2026
- Primary completion date
- 21 Sept 2029
- Lead sponsor
- BeOne Medicines
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07836530
- EU CT number
- 2026-526462-25-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 492
- From Oct 2026 to the primary completion date, 21 Sept 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior therapy targeting GPC3 or 4-1BB
- Participants not feasible to be treated with lenvatinib or sorafenib
- prior exposure to both medications
- siginificant precautions of administering lenvatinib or sorafenib such as clinically significant active bleeding within 3 months prior to first dose, tumor thombus involving main portal vein trunk, inferior vena cava, or cardiac involvement,
- any history of gastrointestinal perforation or larger than grade 3 fistula within 6 months prior to the first dose,
- or any history of heart failure meeting NYHA classification III or IV ≤ 6 months before the first dose of study drug.
- History of previous or present encephalopathy
Other illness
- Active leptomeningeal disease or uncontrolled and untreated brain metastasis
- History of liver transplantation
- NOTE: Other eligbility criteria may apply.
Other
- Presence of clinically significant ascites ((≥ Grade 2).
Who the study is looking for
- Participants must have histologically confirmed Hepatocellular Carcinoma (HCC) that is not amenable to curative surgical or locoregional therapies.
- Participants must have documented disease progression or intolerance after at least 1 but not exceeding 2 prior lines of systemic therapy containing Programmed Cell Death Protein 1 / Programmed Death-Ligand 1 (PD-1/PD-L1). Prior cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) targeting therapy or v ascular endothelial growth factor (VEGF) is permitted but not required.
- Glypican-3 (GPC3) expression level must be known for stratification.
- Participants must have at least 1 measurable lesion as assessed by RECIST v1.1
- Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.