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

Hepatocellular Carcinoma Clinical Trial

Official title:

A Randomized, Open-label, Controlled, Multicenter Phase III Clinical Study to Compare the Effectiveness and Safety of IBI310 Combined With Sintilimab Versus Sorafenib in the First-line Treatment of Advanced Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04720716
• Other study ID #: CIBI310C301
• Status: Recruiting
• Phase: Phase 3
• Start date: February 7, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: September 2022
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: Ronghua Zhang
• Phone: 15267110561
• Email: ronghua.zhang[@]innoventbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 490
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• IBI310
IBI310 IV d1, Q6W
• Sintilimab
sintilimab IV d1, Q3W
• Sorafenib
Sorafenib 400mg po

Locations

Country	Name	City	State
China	Fudan Universtiy Zhongshan Hospital	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	Objective response rate (ORR)	Objective response rate (ORR) in two arms based on RECIST V1.1 by the IRRC	up to 24 months after randomization
Secondary	Progression-free survival (PFS)	Progression-free survival (PFS) in two arms based on RECIST V1.1 by the IRRC and investigator	up to 24 months after randomization
Secondary	Duration of response(DOR)	Duration of response(DOR) in two arms based on RECIST V1.1 by the IRRC and investigator	up to 24 months after randomization
Secondary	Disease control rate(DCR)	Disease control rate(DCR) in two arms based on RECIST V1.1 by the IRRC and investigator	up to 24 months after randomization
Secondary	Time to progression(TTP)	Time to progression(TTP) in two arms based on RECIST V1.1 by the IRRC and investigator	up to 24 months after randomization
Secondary	Time to response(TTR)	Time to response(TTR) in two arms based on RECIST V1.1 by the IRRC and investigator	up to 24 months after randomization
Secondary	The incidence and severity of Treatment-Emergent Adverse Events		up to 24 months after randomization