A Randomized, Open-label，Multi-center Study to Evaluate the Efficacy and Safety of the Combination of Sintilimab and IBI305 Compared to Sorafenib in the First-Line Treatment of Patients With Advanced Hepatocellular Carcinoma. （ORIENT-32）

Innovent Biologics (Suzhou) Co. Ltd.1 site in 1 country595 target enrollmentFebruary 11, 2019

ConditionsHepatocellular Carcinoma

InterventionsSintilimab IBI305 Sorafenib

DrugsSintilimab IBI305 Sorafenib

Overview

Phase: Phase 2
Intervention: Sintilimab
Conditions: Hepatocellular Carcinoma
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Enrollment: 595
Locations: 1
Primary Endpoint: Progression-free survival (PFS)
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 study is a randomised, Open-label，Multi-center Study. The primary endpoint is overall survival.

Registry

clinicaltrials.gov

Start Date

February 11, 2019

End Date

December 2022

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•Child-Pugh: \<=7
•Adequate organ and bone marrow function.

Exclusion Criteria

•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.