Phase
Condition
Carcinoma
Treatment
Sintilimab
Bevacizumab
SHR-8068
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Able and willing to provide a written informed consent
≥ 18 years old, both male and female
Unresectable locally advanced or metastatic HCC confirmed byhistopathologically/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
Exclusion Criteria:
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 orreceived 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 beforerandomization
Major surgery within 28 days before randomization or expected to require majorsurgery during the study period
Active infection, or fever of unknown cause ≥ 38.5℃ in the first 7 days ofrandomization, or WBC > 15×109/L at baseline
Known positive history of human immunodeficiency virus test or acquiredimmunodeficiency syndrome, known HBV infection, known HCV infection
Patients who received live vaccines within 28 days before randomization, or areexpected to be vaccinated during the treatment period
Patients with other potential factors that may affect the study results
Study Design
Connect with a study center
Anhui Provincial Hospital
Hefei, Anhui 230000
ChinaActive - Recruiting
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