New Triple-Drug attack on liver cancer enters early human testing
NCT ID NCT07557251
First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 2 times
Summary
This early-phase study tests a new experimental drug (BRII-5395) combined with two approved cancer treatments (sintilimab and bevacizumab) in about 21 adults with advanced liver cancer linked to chronic hepatitis B. The main goal is to check safety and find the right dose, while also looking for signs that the combination shrinks tumors or slows the disease. Participants must have already tried at least one prior cancer therapy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 21 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
RECRUITINGBeijing, China