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.

Hepatocellular Carcinoma Clinical Trial

Official title:

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）

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03794440
• Other study ID #: CIBI338B301
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: February 11, 2019
• Est. completion date: December 2022

Study information

• Verified date: May 2020
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 595
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Sintilimab
200mg IV d1, Q3W
• IBI305
15mg/kg IV d1, Q3W
• Sorafenib
400mg PO BID

Locations

Country	Name	City	State
China	Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)		up to 24 months after randomization
Primary	Progression-free survival (PFS)	Progression-free survival (PFS) in two arms based on RECIST V1.1 by Independent Radiological Review Committee, IRRC.	up to 24 months after randomization
Secondary	PFS	PFS in two arms based on RECIST V1.1 by investigator.	up to 24 months after randomization
Secondary	Objective response rate (ORR)	Objective response rate (ORR) in two arms based on RECIST V1.1 by IRRC and investigator .	up to 24 months after randomization
Secondary	Disease control rate (DCR)	DCR in two arms based on RECIST V1.1 by IRRC and investigator.	up to 24 months after randomization
Secondary	Duration of response (DOR)	DOR in two arms based on RECIST V1.1 by IRRC and investigator.	up to 24 months after randomization
Secondary	Time to progression (TTP)	TTP in two arms based on RECIST V1.1 by IRRC and investigator.	One assessment was performed every 6 weeks (±7 days) from the time of randomization, and once every 12 weeks (±7 days) after 48 weeks.
Secondary	Time to response (TTR)	TTR in two arms based on RECIST V1.1 by IRRC and investigator.	up to 24 months after randomization
Secondary	PFS	PFS in two arms based on mRECIST by IRRC.	up to 24 months after randomization
Secondary	Objective response rate (ORR)	Objective response rate (ORR) in two arms based on mRECIST by IRRC.	up to 24 months after randomization
Secondary	Time to progression (TTP)	TTP in two arms based on mRECIST by IRRC.	up to 24 months after randomization
Secondary	Duration of response (DOR)	DOR in two arms based on mRECIST by IRRC.	up to 24 months after randomization
Secondary	Disease control rate (DCR)	DCR in two arms based on mRECIST by IRRC.	up to 24 months after randomization
Secondary	Time to response (TTR)	TTR in two arms based on mRECIST by IRRC.	up to 24 months after randomization
Secondary	Anti-drug antibody (ADA)	Immunogenicity measured by anti-drug antibody (ADA) for Sintilimab and IBI305.	up to 24 months after randomization
Secondary	EORTC QLQ-C30		up to 24 months after randomization
Secondary	EORTC QLQ-HCC18		up to 24 months after randomization