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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: IBI310
* Drug: Sintilimab
* Drug: Sorafenib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sintilimab combined with IBI310<br> | Drug: IBI310<br>* IBI310 IV d1, Q6W<br>Drug: Sintilimab<br>* sintilimab IV d1, Q3W<br>|
| Active Comparator: Sorafenib<br> | Drug: Sorafenib<br>* Sorafenib 400mg po<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) |  | up to 24 months after randomization | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| The incidence and severity of Treatment-Emergent Adverse Events |  | up to 24 months after randomization | 
| 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 | 
| 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 | 
| 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 | 
| 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 |