Status:
UNKNOWN
A Study to Evaluate the Efficacy and Safety of Sintilimab in Combination With IBI305 (Anti-VEGF Monoclonal Antibody) Compared to Sorafenib as the First-Line Treatment for Advanced Hepatocellular Carcinoma.
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of the study is to assess the safety, tolerability and effectiveness of Sintilimab in combination with IBI305 in patients with HCC as the first-line treatment compared with Sorafenib. This...
Eligibility Criteria
Inclusion
- Hepatocellular carcinoma confirmed by histology/cytology. Cirrhosis meets the clinical diagnostic criteria for hepatocellular carcinoma of the American Association for the Diagnosis of Liver Diseases (AASLD).
- ECOG performance status between 0 and 1
- No systematic anti-tumor treatment has been performed.(End of postoperative adjuvant chemotherapy for more than 6 months allowed).
- Barcelona Clinic Liver Cancer stage C. BCLC stage B, not suitable for radical surgery and/or local treatment.
- At least 1 lesion with measurable disease at baseline by RECIST V1.1.
- Child-Pugh: \<=7
- 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 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
595 Patients enrolled
Trial Details
Trial ID
NCT03794440
Start Date
February 11 2019
End Date
December 1 2022
Last Update
January 22 2021
Active Locations (1)
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1
Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200032