A Phase 1 interventional study of BRII-5395 and Sintilimab in Advanced HBV-Related Hepatocellular Carcinoma, sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Phase 1, Interventional, and Treatment
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Among 16 studies in Carcinoma, Hepatocellular by Cancer Institute and Hospital, Chinese Academy of Medical Sciences — 8 open to participants now, 9 under way, 1 of them phase 3. Carcinoma, Hepatocellular · Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
Among the 16 studies in Carcinoma, Hepatocellular by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, this one is the 13th largest by planned enrollment of the 15 interventional ones that give a count, is one of 2 that started in 2026, is one of 2 in phase 1, and was the 15th registered.
3,650 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,062 are open to participants now.
Browse Carcinoma, Hepatocellular studies →8 of the 16 studies in Carcinoma, Hepatocellular by Cancer Institute and Hospital, Chinese Academy of Medical Sciences are open now, in 1 country. Recruiting first, the newest first:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Sites in China
Ages 18–75
Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Sites in China
Ages 18–75
Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Sites in China
Ages 18–80
Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Sites in China
Ages 18–90
Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Sites in China
Ages 18+
By country, each count listing its studies:
Of the 737 Carcinoma, Hepatocellular studies recruiting now, 382 (52%) set no upper age limit and 249 (34%) stop at 75 or younger; 31 take children under 18; 31 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
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16 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 21 is below the median of 54 across 2,619 interventional studies indexed under Carcinoma, Hepatocellular.
Median enrollment 36 across the 15 interventional studies, 30 across the 1 observational. Of the 5 that completed or were terminated, 1 (20%) have results posted.
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences is the lead sponsor of 394 studies on the registry; 280 are open to participants now.
2 of the studies in Carcinoma, Hepatocellular by Cancer Institute and Hospital, Chinese Academy of Medical Sciences that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07186621Phase 3Cancer Institute and Hospital, Chinese Academy of Medical SciencesAdjuvant Radiotherapy of Sintilimab Versus TACE for HCC | 2027-07-09 |
| NCT07239245Cancer Institute and Hospital, Chinese Academy of Medical SciencesStudy to Evaluate the Efficacy and Safety of Neo-Adjuvant TACE and Atezolizumab Plus Bevacizumab Therapy for High-Risk Recurrent Hepatocellular Carcinamo | 2027-11-10 |
Add all 2 to your calendar (.ics) → With an account.
Among the 16 studies in Carcinoma, Hepatocellular by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive BRII-5395 at protocol-specified dose and schedule, and in combination with sintilimab 200 mg and bevacizumab 15 mg/kg, every 3 weeks. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or loss to follow-up, whichever occurs first.
Drug: BRII-5395 · Drug: Sintilimab · Drug: Bevacizumab
Participants will receive BRII-5395 at a dose level selected from Arm 1, and in combination with sintilimab 200 mg and bevacizumab 15mg/kg, every 3 weeks. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or loss to follow-up, whichever occurs first.
Drug: BRII-5395 · Drug: Sintilimab · Drug: Bevacizumab
BRII-5395 will be given via IM injection
Sintilimab will be given via IV infusion
Bevacizumab will be given via IV infusion
Incidence and type of dose-limiting toxicities (DLTs)
Time frame: Up to 30 days post last dose
Adverse events (AEs) and serious AEs (SAEs)
Time frame: Up to 30 days post last dose
Abnormalities in laboratory and other clinical assessments
Time frame: Up to 30 days post last dose
Objective response rate (ORR)
Time frame: Up to 2 years
Disease control rat (DCR)
Time frame: Up to 2 years
Duration of response (DOR)
Time frame: Up to 2 years
Progression-free survival (PFS)
Time frame: Up to 2 years
Overall survival (OS)
Time frame: Up to 2 years
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Dec 2028, 28 months after the start.
Of 145 non-industry phase 1 interventional studies under Carcinoma, Hepatocellular, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 80. This study's planned 28 months is below that.
Counting every sponsor, half of 248 studies reached it within 49 months; a quarter within 32 and three quarters within 77.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences →