Hepatocellular CarcinomaPhase 3NCT07836530
Study Comparing BGB-B2033 With Sorafenib or Lenvatinib in Relapsed Hepatocellular Carcinoma
A Phase 3 study testing BGB-B2033, Lenvatinib and Sorafenib in people with Hepatocellular Carcinoma and Liver Cancer, run by BeOne Medicines.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Cancer
- What is being tested?
- BGB-B2033, Lenvatinib and Sorafenib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 492 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to 21 Jun 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- Active leptomeningeal disease or uncontrolled and untreated brain metastasis
- History of previous or present encephalopathy
- Presence of clinically significant ascites ((≥ Grade 2).
- History of liver transplantation
- NOTE: Other eligbility criteria may apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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?
Read the detailed description
Hepatocellular carcinoma (HCC) is the most common type of liver cancer. It can develop when abnormal cells in the liver grow uncontrollably and may spread to other parts of the body. For people whose cancer has returned or continued to grow after treatment, additional treatment options are needed.
BGB-B2033 is a new investigational drug designed to bind to a protein called glypican-3 (GPC3), a protein found on certain cancer cells and cells of the immune system, helping the immune system to recognize and attack the cancer cells. Lenvatinib and sorafenib are approved medicines that work by blocking signals that help cancer cells grow and form new blood vessels.
The purpose of this study is to test whether BGB-B2033 is safe and can help treat HCC in adults whose cancer has been treated with up to 2 previous treatments that included programmed cell death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) medicines. The main goal of the study is to see how well BGB-B2033 controls cancer compared to the treatments selected by the study doctor (either lenvatinib or sorafenib).
This study has 2 treatment groups. Participants will be randomly assigned, like flipping a coin, to receive either:
- BGB-B2033, given by intravenous infusion.
- Sorafenib, taken by mouth or lenvatinib, taken by mouth per their doctor's choice The study will enroll approximately 492 adults with HCC at multiple centers worldwide. Participants will make regular visits to the clinic for treatment, health checks, blood tests, and tumor and imaging tests.
The overall study will last about 3.5 years, not including the screening period.
- Conditions
- Hepatocellular Carcinoma, Liver Cancer
- Being tested
- BGB-B2033, Lenvatinib, Sorafenib
- Keywords
- Liver Cancer, Hepatocellular Carcinoma, Sorafenib, Lenvatinib, BGB-B2033
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGB-B2033Drug
Administered intravenously
LenvatinibDrug
Also called Lenvima
Administered by mouth as an oral capsule once daily
SorafenibDrug
Also called Nexavar
Administered by mouth as an oral tablet twice daily
| Study group | Role | What they receive |
|---|---|---|
| BGB-B2033 | Experimental | Participants are randomized to receive BGB-B2033 until disease progression, unacceptable toxicity, withdrawal of consent, death, or the end of the study, whichever occurs first. Receives: Drug: BGB-B2033 |
| Investigator's choice: Lenvatinib OR sorafenib | Active comparator | Participants are randomized to receive either lenvatinib or sorafenib, selected by the investigator before treatment, until disease progression, unacceptable toxicity, withdrawal of consent, death, or the end of the study, whichever occurs first. Receives: Drug: Lenvatinib; Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS is defined as the time from randomization to the date of death from any cause.
Measured: Up to approximately 3.5 years
Secondary outcomes (8)
Overall Response Rate (ORR)
Defined as the percentage of participants who achieved complete response (CR) or partial response (PR) by investigator assessment and Blinded Independent Central Review (BICR) with confirmation per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured: Up to approximately 3.5 years
Duration of Response (DOR)
DOR is defined as the time from the date that a confirmed response (CR or PR) was first observed to the date of first documented disease progression or death, whichever occurred first. Assessed by BIRC and investigator with confirmation per RECIST v1.1.
Measured: Up to approximately 3.5 years
Progression Free Survival Rate (PFS)
PFS is defined as time from start of treatment to the first documentation of disease progression or death, whichever occurs first as determined by investigator assessment and BIRC with confirmation per RECIST v1.1
Measured: Up to approximately 3.5 years
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Immune-Related Adverse Events (imAEs)
Safety will be assessed by monitoring and recording of all adverse events (AEs) graded by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v6.0.
Measured: From first dose until either 30 days after the last dose of study drug(s) or initiation of new anticancer therapy, whichever occurs first (Up to approximately 3.5 years)
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Hepatocellular Carcinoma 18-question module [EORTC QLQ-HCC18]) Fatigue Scores
The EORTC QLQ-HCC18 measures health related quality of life outcomes in participants with liver cancer. The 18-item questionnaire is conceptualized as consisting of 6 symptom domains, 2 single items and an Index score: fatigue (3 items), body image (2 items), jaundice (2 items), nutrition (5 items), pain (2 items), fever (2 items), abdominal swelling (1 item), and sex life (1 item). The Index score is a composite of all 18 items. The items are scored using a verbal-descriptive scale rated from 1 to 4 (1 = "not at all"; 4 = "very much"). Higher scores indicate worse symptoms.
Measured: From baseline (Cycle 1 Day 1, predose) through the Safety Follow-up Visit (30 days after last dose) with assessments every 2 cycles through EOT. Each cycle is 21 days.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Function 17 (EORTC QLQ-F17) Global Health Status (GHS), and Physical/Role Functioning scores
The EORTC QLQ-F17 is a generic core questionnaire that assesses self-reported functioning and GHS in participants with cancer. The EORTC QLQ-F17 includes predefined key participant reported outcomes (PRO) endpoints to measure GHS and physical functioning and role functioning. The functional items are scored on a 4-point verbal-descriptive scale (1 = "not at all"; 4 = "very much"), while the 2 GHS items use a 7-point scale (1 = "very poor"; 7 = "excellent"). Higher scores in GHS and functioning scales indicate better health related quality outcomes.
Measured: From baseline (Cycle 1 Day 1, predose) through the Safety Follow-up Visit (30 days after last dose) with assessments every 2 cycles through EOT.
Time to Deterioration of Fatigue Measured by EORTC QLQ-HCC18
Time to deterioration in fatigue, as measured by the fatigue domain of the EORTC QLQ-HCC18 questionnaire. The fatigue domain consists of 3 items scored from 1 ("not at all") to 4 ("very much"). Higher scores indicate worse fatigue. Time to deterioration is defined as the time from randomization to the first clinically meaningful worsening in the fatigue score from baseline, based on the prespecified scoring criteria.
Measured: From randomization until the first clinically meaningful deterioration, end of treatment, withdrawal of consent, death, or end of study, as applicable (Up to approximately 3.5 years)
Time to Deterioration of Global Health Status and Physical/Role Functioning Measured by EORTC QLQ-F17.
Time to deterioration in global health status, physical functioning, and role functioning, as measured by the EORTC QLQ-F17 questionnaire. The questionnaire assesses participants' self-reported overall health, physical functioning, and ability to perform daily activities and roles. Higher scores indicate better health-related quality of life. Time to deterioration is defined as the time from randomization to the first clinically meaningful worsening from baseline in global health status, physical functioning, or role functioning, based on prespecified scoring criteria.
Measured: From randomization until the first clinically meaningful deterioration, end of treatment, withdrawal of consent, death, or end of study, as applicable ((Up to approximately 3.5 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study startOct 2026 (estimated)
- Primary completion21 Sep 2029 (estimated)
- Study completion21 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by BeOne MedicinesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 492 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeOne Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeOne Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836530
- Sponsor's protocol ID
- BGB-B2033-301
- Other IDs
- 2026-526462-25-00
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07836530
- Acronym / sponsor ID
- BGB-B2033-301
- Conditions
- Hepatocellular Carcinoma, Liver Cancer
- Keywords
- Liver Cancer, Hepatocellular Carcinoma, Sorafenib, Lenvatinib, BGB-B2033
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 492 participants (estimated)
- Lead sponsor
- BeOne MedicinesIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- 21 Sep 2029 (estimated)
- Study completion
- 21 Jun 2030 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
Hepatocellular carcinoma (HCC) is the most common type of liver cancer. It can develop when abnormal cells in the liver grow uncontrollably and may spread to other parts of the body. For people whose cancer has returned or continued to grow after treatment, additional treatment options are needed.
BGB-B2033 is a new investigational drug designed to bind to a protein called glypican-3 (GPC3), a protein found on certain cancer cells and cells of the immune system, helping the immune system to recognize and attack the cancer cells. Lenvatinib and sorafenib are approved medicines that work by blocking signals that help cancer cells grow and form new blood vessels.
The purpose of this study is to test whether BGB-B2033 is safe and can help treat HCC in adults whose cancer has been treated with up to 2 previous treatments that included programmed cell death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) medicines. The main goal of the study is to see how well BGB-B2033 controls cancer compared to the treatments selected by the study doctor (either lenvatinib or sorafenib).
This study has 2 treatment groups. Participants will be randomly assigned, like flipping a coin, to receive either:
- BGB-B2033, given by intravenous infusion.
- Sorafenib, taken by mouth or lenvatinib, taken by mouth per their doctor's choice The study will enroll approximately 492 adults with HCC at multiple centers worldwide. Participants will make regular visits to the clinic for treatment, health checks, blood tests, and tumor and imaging tests.
The overall study will last about 3.5 years, not including the screening period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BGB-B2033 | Experimental | Drug: BGB-B2033Participants are randomized to receive BGB-B2033 until disease progression, unacceptable toxicity, withdrawal of consent, death, or the end of the study, whichever occurs first. |
| Investigator's choice: Lenvatinib OR sorafenib | Active comparator | Drug: Lenvatinib, Drug: SorafenibParticipants are randomized to receive either lenvatinib or sorafenib, selected by the investigator before treatment, until disease progression, unacceptable toxicity, withdrawal of consent, death, or the end of the study, whichever occurs first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- Prior therapy targeting GPC3 or 4-1BB
- Participants not feasible to be treated with lenvatinib or sorafenib
- Active leptomeningeal disease or uncontrolled and untreated brain metastasis
- History of previous or present encephalopathy
- Presence of clinically significant ascites ((≥ Grade 2).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BGB-B2033Administered intravenously | Drug | BGB-B2033 |
| LenvatinibAlso: LenvimaAdministered by mouth as an oral capsule once daily | Drug | Investigator's choice: Lenvatinib OR sorafenib |
| SorafenibAlso: NexavarAdministered by mouth as an oral tablet twice daily | Drug | Investigator's choice: Lenvatinib OR sorafenib |
Primary outcome
Overall Survival (OS)
Time frame: Up to approximately 3.5 years
OS is defined as the time from randomization to the date of death from any cause.
8 secondary outcomes
Overall Response Rate (ORR)
Time frame: Up to approximately 3.5 years
Duration of Response (DOR)
Time frame: Up to approximately 3.5 years
Progression Free Survival Rate (PFS)
Time frame: Up to approximately 3.5 years
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Immune-Related Adverse Events (imAEs)
Time frame: From first dose until either 30 days after the last dose of study drug(s) or initiation of new anticancer therapy, whichever occurs first (Up to approximately 3.5 years)
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Hepatocellular Carcinoma 18-question module [EORTC QLQ-HCC18]) Fatigue Scores
Time frame: From baseline (Cycle 1 Day 1, predose) through the Safety Follow-up Visit (30 days after last dose) with assessments every 2 cycles through EOT. Each cycle is 21 days.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Function 17 (EORTC QLQ-F17) Global Health Status (GHS), and Physical/Role Functioning scores
Time frame: From baseline (Cycle 1 Day 1, predose) through the Safety Follow-up Visit (30 days after last dose) with assessments every 2 cycles through EOT.
Time to Deterioration of Fatigue Measured by EORTC QLQ-HCC18
Time frame: From randomization until the first clinically meaningful deterioration, end of treatment, withdrawal of consent, death, or end of study, as applicable (Up to approximately 3.5 years)
Time to Deterioration of Global Health Status and Physical/Role Functioning Measured by EORTC QLQ-F17.
Time frame: From randomization until the first clinically meaningful deterioration, end of treatment, withdrawal of consent, death, or end of study, as applicable ((Up to approximately 3.5 years).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: Yes. BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director study director
BeOne Medicines
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BGB-B2033, Lenvatinib and Sorafenib in people with Hepatocellular Carcinoma and Liver Cancer, run by BeOne Medicines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Director (1-877-828-5568, clinicaltrials@beonemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Up to approximately 3.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.