NCT07557251RecruitingPhase 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
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
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (estimated)
- First submitted
- 7 Apr 2026
- Start date
- Aug 2026
- Primary completion date
- Dec 2028
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- NCT number
- NCT07557251
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 21
- From Aug 2026 to the primary completion date, Dec 2028
- 1 site in 1 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
- 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.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.