A Study to Compare the Effectiveness and Safety of IBI310 Combined With Sintilimab Versus Sorafenib in the First-line Treatment of Advanced HCC

Launched by INNOVENT BIOLOGICS (SUZHOU) CO. LTD. · Jan 20, 2021

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Histologically/cytologically confirmed hepatocellular carcinoma, or liver cirrhosis meeting the clinical diagnostic criteria;
• • 2. ECOG performance status score of 0 or 1 point;
• • 3. No systemic antitumor treatment for hepatocellular carcinoma before the first administration;
• • 4. Barcelona Clinic Liver Cancer stage C, or Stage B not suitable for radical surgery and/or local treatment;
• • 5. At least 1 measurable lesion according to RECIST V1.1);
• • 6. Child-Pugh:≤6
• • 7. Adequate organ and bone marrow function.
• Exclusion Criteria:
• • 1. With fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues.
• • 2. Have a history of hepatic encephalopathy or have a history of liver transplantation.
• • 3. With clinical symptoms requires drainage of pleural effusion, ascites or pericardial effusion.
• • 4. Central nervous system (CNS) metastasis.
• • 5. Uncontrolled high blood pressure, systolic blood pressure \>140mmHg or diastolic blood pressure \>90mmHg after optimal medical treatment.
• • 6. Local treatment for liver lesions within 4 weeks.