Evaluate the Safety and Efficacy of Toripalimab Combined With Bevacizumab Versus Sorafenib Therapy for HCC
- Trial number:
- NCT04723004
- Trial phase:
- 3
- Study type:
- Targeted therapy, Immunotherapy
- Overall status:
- Active, not recruiting
Study start date
Scientific title
Summary
Age of 18-75 years (inclusive), male or female.Histological or cytological diagnosis of HCC or clinical diagnosis of HCC in cirrhotic patients per the American Association for the Study of Liver Diseases (AASLD) guideline. Unresectable BCLC B/C No previous systemic therapy for HCC, patients with prior adjuvant therapy alone who relapsed at 6 months or above after the last adjuvant therapy may be enrolled. ≥ 1 measurable lesion per RECISTv1.1. Child-Pugh class A, with no history of hepatic encephalopathy. ECOG PS 0 or 1. Predicted life expectancy ≥12 weeks. adequate main organ functions In case of HBsAg (+) and/or HBcAb (+), HBV DNA is required to be < 2000 IU/mL. Patients with anti-HCV antibody positive and HCV- RNA>1000 copies/mL will be excluded; HBV/HCV co-infected patients will be excluded. patients with a prior history of HCV infection who tested negative for HCV-RNA can be considered HCV uninfected. Female subjects of childbearing potential must receive serum pregnancy test within 7 days before randomization and the result should be negative, and should be willing to adopt reliable and effective contraceptive methods during the trial and within 60 days after the last dose of study drug. The male patients whose partners are women of childbearing potential must agree to use reliable and effective contraceptive methods during the trial and within 60 days after the last dose of study drug. Being voluntary to participate in the study, sufficiently informed consent and signature of written informed consent form, with good compliance.