Study of SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab Combined With Bevacizumab for the Treatment of Advanced Hepatocellular Carcinoma
A Randomized, Controlled, Open-label, Multicenter Phase III Clinical Study of Anti CTLA-4 Antibody SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab Combined With Bevacizumab for the First-line Treatment of Advanced Hepatocellular Carcinoma
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
590 participants
Oct 28, 2024
INTERVENTIONAL
Conditions
Summary
To evaluate the efficacy of SHR-8068 combined with Adebrelimab and Bevacizumab compared with Sintilimab combined with Bevacizumab for the first-line treatment of advanced HCC
Eligibility
Inclusion Criteria11
- Able and willing to provide a written informed consent
- ≥ 18 years old, both male and female
- Unresectable locally advanced or metastatic HCC confirmed by histopathologically/cytologically
- At least one measurable lesion based on RECIST v1.1 criteria
- Barcelona clinic liver cancer: Stage B or C
- No previous systemic antitumor therapy for HCC
- ECOG PS of 0-1
- Child-Pugh score of A or B7
- Expected survival period ≥ 12 weeks
- Adequate organ function
- Blood pregnancy negative (women of childbearing age) and non-breastfeeding, effective contraception
Exclusion Criteria16
- Hepatic cholangiocarcinoma, mixed hepatocellular carcinoma -cholangiocarcinoma, sarcomatoid hepatocellular carcinoma and fibrolamellar hepatocellular carcinoma
- Patients with other malignancies currently or within the past 5 years
- With known severe allergic reactions to any other monoclonal antibodies
- Patients with known CNS metastasis or hepatic encephalopathy
- Patients with liver tumor burden greater than 50% of total liver in volume or received liver transplants
- Patients with symptomatic ascites or pleural effusion
- Patients with hypertension which cannot be well controlled by antihypertensives
- Uncontrolled cardiac diseases or symptoms
- Known hereditary or acquired bleeding (e.g., coagulopathy) or a tendency to clot (e.g., hemophiliacs)
- Major vascular disease occurred in the 6 months before randomization
- Gastrointestinal perforation or gastrointestinal fistula within 6 months before randomization
- Major surgery within 28 days before randomization or expected to require major surgery during the study period
- Active infection, or fever of unknown cause ≥ 38.5℃ in the first 7 days of randomization, or WBC \> 15×109/L at baseline
- Known positive history of human immunodeficiency virus test or acquired immunodeficiency syndrome, known HBV infection, known HCV infection
- Patients who received live vaccines within 28 days before randomization, or are expected to be vaccinated during the treatment period
- Patients with other potential factors that may affect the study results
Interventions
SHR-8068: injection, 50 mg/10 mL, intravenous infusion
Adebrelimab: injection, 600 mg/12 mL, intravenous infusion
Bevacizumab: injection, 100 mg/4 mL, intravenous infusion
Sintilimab: injection, 100 mg/10 mL, intravenous infusion
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06618664