Advanced HBV-Related Hepatocellular CarcinomaPhase 1NCT07557251
A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of BRII-5395 in Combination With Sintilimab and Bevacizumab in Advanced Hepatitis B Virus Related Hepatocellular Carcinoma
A Phase 1 study testing BRII-5395, Sintilimab and Bevacizumab in people with Advanced HBV-Related Hepatocellular Carcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This early phase (Phase 1) study will evaluate BRII 5395, administered in combination with two approved anticancer agents, sintilimab and bevacizumab, in patients with advanced liver cancer caused by chronic hepatitis B virus (HBV) infection. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced HBV-Related Hepatocellular Carcinoma
- What is being tested?
- BRII-5395, Sintilimab and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 12 Aug 2026to Dec 2028
- Phase
- Phase 1
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of locally advanced or metastatic HCC that is deemed unsuitable for surgical resection or transplant.
- BCLC stages Intermediate (B) or Advanced (C).
- Failed at least first-line systemic therapy, including ICIs; and disease is not amenable to curative surgical and/or locoregional therapies.
- Adequate bone marrow and organ function status.
- Life expectancy > 3 months.
- HBsAg > 0.05 IU/mL at screening.
Who cannot join
- Any systemic anticancer therapy within specified period prior to the first dose of study treatment.
- Any localized anticancer therapy within specified period prior to the first dose of study treatment.
- History of anaphylactic hypersensitivity prior to the first dose of study treatment.
- Known hypersensitivity to polyethylene glycol or any component of sintilimab or bevacizumab formulation, or any contraindications to sintilimab or bevacizumab.
- Presence of cancer or metastasis in the central nervous system with clinical symptoms.
- Remaining ≥ NCI-CTCAE grade 2 toxicities from previous anticancer therapy, unless otherwise specified.
- Current or past history of infection with HIV, HCV, or active tuberculosis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing
Ning Li, Dr.
About this study
Official title: An Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of BRII-5395 in Combination With Sintilimab and Bevacizumab in Participants With Advanced Hepatitis B Virus Related Hepatocellular Carcinoma
This early phase (Phase 1) study will evaluate BRII 5395, administered in combination with two approved anticancer agents, sintilimab and bevacizumab, in patients with advanced liver cancer caused by chronic hepatitis B virus (HBV) infection. The primary objective of the study is to assess the safety and tolerability of the combination therapy, as well as to explore preliminary evidence of clinical benefit.
- Being tested
- BRII-5395, Sintilimab, Bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRII-5395Drug
BRII-5395 will be given via IM injection
SintilimabDrug
Sintilimab will be given via IV infusion
BevacizumabDrug
Bevacizumab will be given via IV infusion
| Study group | Role | What they receive |
|---|---|---|
| BRII-5395 dose escalation | Experimental | Participants will receive BRII-5395 at protocol-specified dose and schedule, and in combination with sintilimab 200 mg and bevacizumab 15 mg/kg, every 3 weeks. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or loss to follow-up, whichever occurs first. Receives: Drug: BRII-5395; Drug: Sintilimab; Drug: Bevacizumab |
| BRII-5395 dose expansion | Experimental | Participants will receive BRII-5395 at a dose level selected from Arm 1, and in combination with sintilimab 200 mg and bevacizumab 15mg/kg, every 3 weeks. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or loss to follow-up, whichever occurs first. Receives: Drug: BRII-5395; Drug: Sintilimab; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and type of dose-limiting toxicities (DLTs)
Measured: Up to 30 days post last dose
Adverse events (AEs) and serious AEs (SAEs)
Measured: Up to 30 days post last dose
Abnormalities in laboratory and other clinical assessments
Measured: Up to 30 days post last dose
Secondary outcomes (5)
Objective response rate (ORR)
Measured: Up to 2 years
Disease control rat (DCR)
Measured: Up to 2 years
Duration of response (DOR)
Measured: Up to 2 years
Progression-free survival (PFS)
Measured: Up to 2 years
Overall survival (OS)
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start12 Aug 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced HBV-Related Hepatocellular CarcinomaStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shuhang Wang, Dr., Study director, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557251
- Sponsor's protocol ID
- BRII-5395-001
- Status last verified
- Aug 2026
- First submitted
- 7 Apr 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of BRII-5395 in Combination With Sintilimab and Bevacizumab in Participants With Advanced Hepatitis B Virus Related Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07557251
- Acronym / sponsor ID
- BRII-5395-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 12 Aug 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 29 Apr 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.
This early phase (Phase 1) study will evaluate BRII 5395, administered in combination with two approved anticancer agents, sintilimab and bevacizumab, in patients with advanced liver cancer caused by chronic hepatitis B virus (HBV) infection. The primary objective of the study is to assess the safety and tolerability of the combination therapy, as well as to explore preliminary evidence of clinical benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BRII-5395 dose escalation | Experimental | Drug: BRII-5395, Drug: Sintilimab, Drug: BevacizumabParticipants will receive BRII-5395 at protocol-specified dose and schedule, and in combination with sintilimab 200 mg and bevacizumab 15 mg/kg, every 3 weeks. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or loss to follow-up, whichever occurs first. |
| BRII-5395 dose expansion | Experimental | Drug: BRII-5395, Drug: Sintilimab, Drug: BevacizumabParticipants will receive BRII-5395 at a dose level selected from Arm 1, and in combination with sintilimab 200 mg and bevacizumab 15mg/kg, every 3 weeks. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or loss to follow-up, whichever occurs first. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of locally advanced or metastatic HCC that is deemed unsuitable for surgical resection or transplant.
- BCLC stages Intermediate (B) or Advanced (C).
- Failed at least first-line systemic therapy, including ICIs; and disease is not amenable to curative surgical and/or locoregional therapies.
- Adequate bone marrow and organ function status.
- Life expectancy > 3 months.
Key exclusion criteria (7 listed)
- Any systemic anticancer therapy within specified period prior to the first dose of study treatment.
- Any localized anticancer therapy within specified period prior to the first dose of study treatment.
- History of anaphylactic hypersensitivity prior to the first dose of study treatment.
- Known hypersensitivity to polyethylene glycol or any component of sintilimab or bevacizumab formulation, or any contraindications to sintilimab or bevacizumab.
- Presence of cancer or metastasis in the central nervous system with clinical symptoms.
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 |
|---|---|---|
| BRII-5395BRII-5395 will be given via IM injection | Drug | BRII-5395 dose escalation, BRII-5395 dose expansion |
| SintilimabSintilimab will be given via IV infusion | Drug | BRII-5395 dose escalation, BRII-5395 dose expansion |
| BevacizumabBevacizumab will be given via IV infusion | Drug | BRII-5395 dose escalation, BRII-5395 dose expansion |
Primary outcome
Incidence and type of dose-limiting toxicities (DLTs)
Time frame: Up to 30 days post last dose
Adverse events (AEs) and serious AEs (SAEs)
Time frame: Up to 30 days post last dose
Abnormalities in laboratory and other clinical assessments
Time frame: Up to 30 days post last dose
5 secondary outcomes
Objective response rate (ORR)
Time frame: Up to 2 years
Disease control rat (DCR)
Time frame: Up to 2 years
Duration of response (DOR)
Time frame: Up to 2 years
Progression-free survival (PFS)
Time frame: Up to 2 years
Overall survival (OS)
Time frame: Up to 2 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 31 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Shuhang Wang, Dr. study director
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BRII-5395, Sintilimab and Bevacizumab in people with Advanced HBV-Related Hepatocellular Carcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Ning Li, Dr. (+8601087788713, lining@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and type of dose-limiting toxicities (DLTs) (time frame: Up to 30 days post last dose). The study lists 3 primary outcomes in all. 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 31 Aug 2026.