Combination therapy with BRII-5395, sintilimab, and bevacizumab in advanced HBV-related hepatocellular carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 trial evaluating the safety and tolerability of BRII-5395 in combination with sintilimab and bevacizumab in patients with advanced hepatocellular carcinoma related to chronic hepatitis B. Eligible participants have locally advanced or metastatic disease not suitable for surgery, have failed prior therapies (including ICIs), and have adequate organ function. The study will monitor adverse events and collect preliminary signals of clinical activity to inform future research. Enrollment is focused at the Cancer Institute and Hospital, Chinese Academy of Medical Sciences in Beijing. No collaborators are listed for this trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Diagnosis of locally advanced or metastatic HCC that is deemed unsuitable for surgical resection or transplant.
2. BCLC stages Intermediate (B) or Advanced (C).
3. Failed at least first-line systemic therapy, including ICIs; and disease is not amenable to curative surgical and/or locoregional therapies.
4. Adequate bone marrow and organ function status.
5. Life expectancy \> 3 months.
6. HBsAg \> 0.05 IU/mL at screening.

Exclusion Criteria:

1. Any systemic anticancer therapy within specified period prior to the first dose of study treatment.
2. Any localized anticancer therapy within specified period prior to the first dose of study treatment.
3. History of anaphylactic hypersensitivity prior to the first dose of study treatment.
4. Known hypersensitivity to polyethylene glycol or any component of sintilimab or bevacizumab formulation, or any contraindications to sintilimab or bevacizumab.
5. Presence of cancer or metastasis in the central nervous system with clinical symptoms.
6. Remaining ≥ NCI-CTCAE grade 2 toxicities from previous anticancer therapy, unless otherwise specified.
7. Current or past history of infection with HIV, HCV, or active tuberculosis.

Where it's running

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  Beijing, China Recruiting

Study contacts

• Study coordinator: Ning Li, Dr.
• Email: lining@cicams.ac.cn
• Phone: +8601087788713

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.