Phase
Condition
Liver Disease
Liver Cancer
Hepatic Fibrosis
Treatment
N/AClinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
age:18-75 years, male or femal.
Hepatocellular carcinoma confirmed by histopathology, Child-Pugh A .
BCLC staging is stage B or C, preoperative assessment of no extrahepatic metastases.
ECOG Performance Status 0-1.
Alpha-fetoprotein (AFP) decreased to normal,3-4 weeks after surgery. If it is notnormal, it must be checked that there is no clear lesion in MRI or CT.
Adequate organ function.
Patient has given written informed consent.
Exclusion
Exclusion Criteria:
No anti-tumor treatment for hepatocellular carcinoma, including chemotherapy andtopical treatment, before surgery.
Known history of hypersensitivity to macromolecular protein preparation or anycomponents of the SHR- 1210 formulation.
Tumors are not completely removed, or postoperative pathology suggestsnon-hepatocellular carcinoma or other malignant components;
Subjects with any active autoimmune disease or history of autoimmune disease
Uncontrolled clinically significant heart disease, including but not limited to thefollowing: (1) > NYHA II congestive heart failure; (2) unstable angina, (3) myocardialinfarction within the past 1 year; (4) clinically significant supraventriculararrhythmia or ventricular arrhythmia requirement for treatment or intervention;
Active infection or an unexplained fever > 38.5°C during screening or before the firstscheduled day of dosing (subjects with tumor fever may be enrolled at the discretionof the investigator);
Received a live vaccine within 4 weeks of the first dose of study medication.
Pregnancy or breast feeding.
Decision of unsuitableness by principal investigator or physician-in- charge.
Study Design
Connect with a study center
Zhongshan Hospital
Shanghai, Shanghai 200032
ChinaActive - Recruiting

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