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.

Phase 2

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Sintilimab; Drug: Sorafenib; Drug: IBI305

• Registration Number: NCT03794440
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-03
• Study First Submitted QC: 2019-01-03
• Study First Posted: 2019-01-07
• Study Start: 2019-02-11
• Status Verified: 2020-05
• Last Update Submitted: 2021-01-21
• Last Update Posted: 2021-01-22
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 595

Inclusion Criteria

1. 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).
2. ECOG performance status between 0 and 1
3. No systematic anti-tumor treatment has been performed.(End of postoperative adjuvant chemotherapy for more than 6 months allowed).
4. Barcelona Clinic Liver Cancer stage C. BCLC stage B, not suitable for radical surgery and/or local treatment.
5. At least 1 lesion with measurable disease at baseline by RECIST V1.1.
6. Child-Pugh: <=7
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sintilimab +IBI305	Sintilimab	-
Sintilimab +IBI305	IBI305	-
Sorafenib	Sorafenib	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	up to 24 months after randomization	Progression-free survival (PFS) in two arms based on RECIST V1.1 by Independent Radiological Review Committee, IRRC.
Overall survival (OS)	up to 24 months after randomization

Secondary Outcome Measures

Name	Time	Method
EORTC QLQ-C30	up to 24 months after randomization
PFS	up to 24 months after randomization	PFS in two arms based on mRECIST by IRRC.
Objective response rate (ORR)	up to 24 months after randomization	Objective response rate (ORR) in two arms based on mRECIST by IRRC.
Disease control rate (DCR)	up to 24 months after randomization	DCR in two arms based on mRECIST by IRRC.
Duration of response (DOR)	up to 24 months after randomization	DOR in two arms based on mRECIST by IRRC.
Time to progression (TTP)	up to 24 months after randomization	TTP in two arms based on mRECIST by IRRC.
Time to response (TTR)	up to 24 months after randomization	TTR in two arms based on mRECIST by IRRC.
Anti-drug antibody (ADA)	up to 24 months after randomization	Immunogenicity measured by anti-drug antibody (ADA) for Sintilimab and IBI305.
EORTC QLQ-HCC18	up to 24 months after randomization

Trial Locations

Locations (1)

Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China