SCT-I10A Plus SCT510 Versus Sorafenib as First-Line Therapy for Advanced Hepatocellular Carcinoma

Study Overview
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Brief Summary
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The purpose of the study is to assess the safety and effectiveness of SCT-I10A in combination with SCT510 in patients with HCC who have not received prior systemic therapy.

Official Title
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SCT-I10A in Combination With SCT510 Versus Sorafenib as First-Line Therapy for Advanced Hepatocellular Carcinoma (HCC): A Multicenter, Randomized, Open-label,Phase 2/3 Trial

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: SCT-I10A
* Drug: SCT510
* Drug: Sorafenib 200mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must have a diagnosis of HCC not suitable for radical surgery and/or local treatment，or progressed after surgery and/or local treatment. No prior systemic therapy for HCC(End of postoperative adjuvant chemotherapy for more than 6 months allowed). Child-Pugh ≤7 , no history of hepatic encephalopathy. Barcelona Clinic Liver Cancer stage B, not suitable for local treatment and BCLC C. At least one measurable lesion based on Recist1.1 Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. Adequate hematologic and organ function. Exclusion Criteria: Local treatment or surgery for liver lesions within 4 weeks. Prior liver or other organ transplantation. Active Central nervous system (CNS) metastasis or leptomeningeal metastases. Gastrointestinal perforation and/or fistula or intraperitoneal abscess within 6 months prior to the start of study treatment. Hemorrhage tendency or high-risk for bleeding , severe coagulation disorders. Active known, or suspected autoimmune disease. Any condition that is not suitable for participate in this study as determined by investigator.

Ages Eligible for Study
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Minimum Age: 18 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: SCT-I10A+SCT510<br> | Drug: SCT-I10A<br>* Participants receive SCT-I10A intravenously，200mg，d1，Q3w<br>Drug: SCT510<br>* Participants receive SCT510 intravenously，15mg/kg，d1，Q3w<br>|
| Active Comparator: Sorafenib<br> | Drug: Sorafenib 200mg<br>* Participants receive sorafenib orally，400mg bid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) |  | up to 3years | 
| Progression-free survival(PFS)evaluated by the Blinded Independent Central Review Committee (BICR) based on RECIST V1.1 |  | up to 3years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | PFS evaluated by investigator based on RECIST V1.1 | up to 3years | 
| PFS | PFS evaluated by BICR based on mRECIST. | up to 3years | 
| Objective response rate (ORR) | ORR evaluated by BICR based on RECIST V1.1. | up to 3years | 
| ORR | ORR evaluated by BICR based on mRECIST. | up to 3years | 
| ORR | ORR evaluated by investigator based on RECIST V1.1 | up to 3years | 
| Serum concentration of SCT-I10A and SCT510 |  | up to 3years | 
| Anti-drug antibody (ADA) |  | up to 3years |