A Study to Compare the Effectiveness and Safety of IBI310 Combined With Sintilimab Versus Sorafenib in the First-line Treatment of Advanced HCC

Phase 3

Recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: IBI310; Drug: Sorafenib; Drug: Sintilimab

• Registration Number: NCT04720716
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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 metastatic HCC who have not previously received systemic therapy, are unsuitable for radical surgical resection or local treatment, or have had progressive disease after surgical resection or local treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-13
• Study First Submitted QC: 2021-01-20
• Study First Posted: 2021-01-22
• Study Start: 2021-02-07
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-16
• Last Update Posted: 2022-09-19
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 490

Inclusion Criteria

1. Histologically/cytologically confirmed hepatocellular carcinoma, or liver cirrhosis meeting the clinical diagnostic criteria;
2. ECOG performance status score of 0 or 1 point;
3. No systemic antitumor treatment for hepatocellular carcinoma before the first administration;
4. Barcelona Clinic Liver Cancer stage C, or Stage B not suitable for radical surgery and/or local treatment;
5. At least 1 measurable lesion according to RECIST V1.1);
6. Child-Pugh:≤6
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 combined with IBI310	IBI310	-
Sintilimab combined with IBI310	Sintilimab	-
Sorafenib	Sorafenib	-

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	up to 24 months after randomization
Objective response rate (ORR)	up to 24 months after randomization	Objective response rate (ORR) in two arms based on RECIST V1.1 by the IRRC

Secondary Outcome Measures

Name	Time	Method
Duration of response(DOR)	up to 24 months after randomization	Duration of response(DOR) in two arms based on RECIST V1.1 by the IRRC and investigator
Disease control rate(DCR)	up to 24 months after randomization	Disease control rate(DCR) in two arms based on RECIST V1.1 by the IRRC and investigator
Time to response(TTR)	up to 24 months after randomization	Time to response(TTR) in two arms based on RECIST V1.1 by the IRRC and investigator
The incidence and severity of Treatment-Emergent Adverse Events	up to 24 months after randomization
Time to progression(TTP)	up to 24 months after randomization	Time to progression(TTP) in two arms based on RECIST V1.1 by the IRRC and investigator
Progression-free survival (PFS)	up to 24 months after randomization	Progression-free survival (PFS) in two arms based on RECIST V1.1 by the IRRC and investigator

Trial Locations

Locations (1)

Fudan Universtiy Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China