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

Innovent Biologics

Status and phase

Enrolling

Phase 3

Conditions

Hepatocellular Carcinoma

Treatments

Drug: Sorafenib

Drug: Sintilimab

Drug: IBI310

Study type

Interventional

Funder types

Industry

Identifiers

NCT04720716

CIBI310C301

Details and patient eligibility

About

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.

Enrollment

490 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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