Status:
UNKNOWN
A Study to Compare the Effectiveness and Safety of IBI310 Combined With Sintilimab Versus Sorafenib in the First-line Treatment of Advanced HCC
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This is a randomized, open-label, controlled, multicenter Phase III study to evaluate the effectiveness and safety of IBI310 combined with sintilimab and sorafenib in patients with locally advanced or...
Eligibility Criteria
Inclusion
- Histologically/cytologically confirmed hepatocellular carcinoma, or liver cirrhosis meeting the clinical diagnostic criteria;
- ECOG performance status score of 0 or 1 point;
- No systemic antitumor treatment for hepatocellular carcinoma before the first administration;
- Barcelona Clinic Liver Cancer stage C, or Stage B not suitable for radical surgery and/or local treatment;
- At least 1 measurable lesion according to RECIST V1.1);
- Child-Pugh:≤6
- Adequate organ and bone marrow function.
Exclusion
- With fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues.
- Have a history of hepatic encephalopathy or have a history of liver transplantation.
- With clinical symptoms requires drainage of pleural effusion, ascites or pericardial effusion.
- Central nervous system (CNS) metastasis.
- Uncontrolled high blood pressure, systolic blood pressure \>140mmHg or diastolic blood pressure \>90mmHg after optimal medical treatment.
- Local treatment for liver lesions within 4 weeks.
Key Trial Info
Start Date :
February 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
490 Patients enrolled
Trial Details
Trial ID
NCT04720716
Start Date
February 7 2021
End Date
December 1 2023
Last Update
September 19 2022
Active Locations (1)
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1
Fudan Universtiy Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200000