Study of SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab Combined With Bevacizumab for the Treatment of Advanced Hepatocellular Carcinoma
NCT ID: NCT06618664
Last Updated: 2025-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
590 participants
INTERVENTIONAL
2024-10-28
2030-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of SHR-8068 Combined With Adebrelimab and Bevacizumab in the Treatment of Advanced Hepatocellular Carcinoma
NCT05444088
Hepatic Artery Infusion of Adebrelimab Combined With Bevacizumab in the Treatment of Advanced Hepatocellular Carcinoma With Failure of Systemic Therapy Combined With Interventional Therapy
NCT05975463
A Study of QL1706 in Combination With Bevacizumab and/or Chemotherapy as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
NCT05976568
Anti-PD-1/PD-L1 Combined With Anti-angiogenic Agents as First-line Treatment for Unresectable HCC
NCT06360042
Sintilimab and Bevacizumab Combined With Radiotherapy for Advanced Hepatocellular Carcinoma
NCT05010434
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SHR-8068 combined with Adebrelimab and Bevacizumab
SHR-8068
SHR-8068: injection, 50 mg/10 mL, intravenous infusion
Adebrelimab
Adebrelimab: injection, 600 mg/12 mL, intravenous infusion
Bevacizumab
Bevacizumab: injection, 100 mg/4 mL, intravenous infusion
Sintilimab combined with Bevacizumab
Bevacizumab
Bevacizumab: injection, 100 mg/4 mL, intravenous infusion
Sintilimab
Sintilimab: injection, 100 mg/10 mL, intravenous infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SHR-8068
SHR-8068: injection, 50 mg/10 mL, intravenous infusion
Adebrelimab
Adebrelimab: injection, 600 mg/12 mL, intravenous infusion
Bevacizumab
Bevacizumab: injection, 100 mg/4 mL, intravenous infusion
Sintilimab
Sintilimab: injection, 100 mg/10 mL, intravenous infusion
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. ≥ 18 years old, both male and female
3. Unresectable locally advanced or metastatic HCC confirmed by histopathologically/cytologically
4. At least one measurable lesion based on RECIST v1.1 criteria
5. Barcelona clinic liver cancer: Stage B or C
6. No previous systemic antitumor therapy for HCC
7. ECOG PS of 0-1
8. Child-Pugh score of A or B7
9. Expected survival period ≥ 12 weeks
10. Adequate organ function
11. Blood pregnancy negative (women of childbearing age) and non-breastfeeding, effective contraception
Exclusion Criteria
2. Patients with other malignancies currently or within the past 5 years
3. With known severe allergic reactions to any other monoclonal antibodies
4. Patients with known CNS metastasis or hepatic encephalopathy
5. Patients with liver tumor burden greater than 50% of total liver in volume or received liver transplants
6. Patients with symptomatic ascites or pleural effusion
7. Patients with hypertension which cannot be well controlled by antihypertensives
8. Uncontrolled cardiac diseases or symptoms
9. Known hereditary or acquired bleeding (e.g., coagulopathy) or a tendency to clot (e.g., hemophiliacs)
10. Major vascular disease occurred in the 6 months before randomization
11. Gastrointestinal perforation or gastrointestinal fistula within 6 months before randomization
12. Major surgery within 28 days before randomization or expected to require major surgery during the study period
13. Active infection, or fever of unknown cause ≥ 38.5℃ in the first 7 days of randomization, or WBC \> 15×109/L at baseline
14. Known positive history of human immunodeficiency virus test or acquired immunodeficiency syndrome, known HBV infection, known HCV infection
15. Patients who received live vaccines within 28 days before randomization, or are expected to be vaccinated during the treatment period
16. Patients with other potential factors that may affect the study results
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Anhui Provincial Hospital
Hefei, Anhui, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SHR-8068-301
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.