Actively Recruiting
A Randomized, Controlled, Open-label Phase III Study of SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab or Atezolizumab Combined With Bevacizumab for First-line Treatment of Advanced Hepatocellular Carcinoma
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2026-05-04
590
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of SHR-8068 combined with Adebrelimab and Bevacizumab compared with Sintilimab or Atezolizumab combined with Bevacizumab as first-line treatments for advanced hepatocellular carcinoma (HCC). This phase III clinical trial focuses on patients with unresectable locally advanced or metastatic HCC, aiming to understand how these drug combinations perform in managing this serious liver cancer. Participants receive intravenous infusions of study drugs according to their assigned group. One group receives SHR-8068, Adebrelimab, and Bevacizumab, while the other group receives either Sintilimab combined with Bevacizumab or Atezolizumab combined with Bevacizumab. The study is randomized and open-label, meaning patients are randomly assigned to a treatment group and both patients and researchers know which treatment is given. Treatments are delivered by injection in cycles as per the study protocol. During the study, participants undergo regular assessments to monitor disease progression and treatment effects, including imaging evaluations based on RECIST v1.1 criteria reviewed by an independent committee. Researchers measure progression-free survival, overall survival, response rates, duration of response, and adverse events up to approximately 36 months. Participants are closely monitored for safety throughout the study, with follow-up visits to evaluate ongoing effects and health status.
CONDITIONS
Brief Title
A Clinical Study of SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab or Atezolizumab Combined With Bevacizumab for the Treatment of Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide a written informed consent.
- 18 years old or older, both male and female.
- Unresectable locally advanced or metastatic hepatocellular carcinoma confirmed by histopathology or cytology.
- At least one measurable tumor lesion based on RECIST v1.1 criteria.
- Barcelona clinic liver cancer stage B or C.
- No previous systemic antitumor therapy for hepatocellular carcinoma.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Child-Pugh liver function score of A or B7.
- Expected survival period of at least 12 weeks.
- Adequate organ function.
- Negative blood pregnancy test for women of childbearing age, non-breastfeeding, and using effective contraception.
You will not qualify if you...
- Hepatic cholangiocarcinoma, mixed hepatocellular carcinoma-cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, or fibrolamellar hepatocellular carcinoma.
- Other malignancies currently or within the past 5 years.
- Known severe allergic reactions to any monoclonal antibodies.
- Known central nervous system metastasis or hepatic encephalopathy.
- Liver tumor burden greater than 50% of total liver volume or history of liver transplant.
- Symptomatic ascites or pleural effusion.
- Hypertension not well controlled by medication.
- Uncontrolled cardiac diseases or symptoms.
- Known bleeding disorders or clotting tendencies.
- Major vascular disease within 6 months before randomization.
- Gastrointestinal perforation or fistula within 6 months before randomization.
- Major surgery within 28 days before randomization or expected during the study.
- Active infection or fever above 38.5°C within 7 days of randomization, or elevated white blood cell count at baseline.
- Positive history of HIV, HBV, or HCV infection.
- Received live vaccines within 28 days before randomization or expected vaccination during treatment.
- Other factors that may affect study results.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 36 months
Participants receive assigned drug combinations through intravenous infusion as first-line treatment for advanced hepatocellular carcinoma.
Regular visits for treatment and monitoring during this period
Duration - Up to approximately 36 months
Participants are monitored for overall survival and safety outcomes after treatment ends.
Visits scheduled as needed for survival and safety assessments
Trial Site Locations
Total: 1 location
1
Anhui Provincial Hospital
Hefei, Anhui, China, 230000
Actively Recruiting
Research Team
X
Xin Shi
Y
Ying Sun
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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