A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of BRII-5395 in Combinatio… (NCT07557251) | Clinical Trial Compass
Not Yet RecruitingPhase 1
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
China21 participantsStarted 2026-05
Plain-language 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. 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence and type of dose-limiting toxicities (DLTs)
Timeframe: Up to 30 days post last dose
2
Adverse events (AEs) and serious AEs (SAEs)
Timeframe: Up to 30 days post last dose
3
Abnormalities in laboratory and other clinical assessments
Timeframe: Up to 30 days post last dose
Trial details
NCT IDNCT07557251
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
. 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.