Trial studying safety and effects for Advanced HBV-Related Hepatocellular Carcinoma
Official title 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
ClinicalTrials.gov ID: NCT07557251
What this study is testing
What is BRII-5395?
BRII-5395 is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for advanced hbv-related hepatocellular carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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.
You likely can't join if
- 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...
- Presence of cancer or metastasis in the central nervous system with clinical symptoms.
- Remaining ≥ NCI-CTCAE grade 2 toxicities from previous anticancer therapy, unless otherwise specified.
See the full eligibility 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.
- 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.
- Remaining ≥ NCI-CTCAE grade 2 toxicities from previous anticancer therapy, unless otherwise specified.
- Current or past history of infection with HIV, HCV, or active tuberculosis.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.