BRII-5395 with sintilimab and bevacizumab for liver cancer linked to hepatitis B
Tests BRII-5395 with two other drugs in adults with hepatitis B-related liver cancer.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced liver cancer caused by long-term hepatitis B infection, whose cancer got worse after earlier drug treatment.
- Age
- 18 to 70 years
- Sex
- All sexes can join.
- Disease stage
- Locally advanced or metastatic liver cancer (HCC) that cannot be removed by surgery or transplant. BCLC stage Intermediate (B) or Advanced (C).
- Earlier treatment
- Must have had at least first-line systemic therapy, including ICIs, and it failed. Must not have had recent anticancer treatment before the first dose, within a specified period.
- Biomarker or test result
- HBsAg above 0.05 IU/mL at screening.
Main reasons for not taking part
- Cancer in the brain or spinal cord that causes symptoms
- Current or past infection with HIV or HCV, or active tuberculosis
- Known allergy to polyethylene glycol, or to sintilimab or bevacizumab
- History of severe allergic reaction (anaphylaxis)
- Side effects of grade 2 or worse still remaining from earlier cancer treatment
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07557251, who can take part
Where in China
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Trial code
- NCT07557251
- Record updated
- 31 August 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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; Remaining ≥ NCI-CTCAE grade 2 toxicities from previous anticancer therapy, unless otherwise specified; 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; Current or past history of infection with HIV, HCV, or active tuberculosis.