SCT-I10A Plus SCT510 Versus Sorafenib as First-Line Therapy for Advanced Hepatocellular Carcinoma
Phase 2
Active, not recruiting
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Registration Number
- NCT04560894
- Lead Sponsor
- Sinocelltech Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 405
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SCT-I10A+SCT510 SCT-I10A - SCT-I10A+SCT510 SCT510 - Sorafenib Sorafenib 200mg -
- Primary Outcome Measures
Name Time Method 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
Name Time Method PFS up to 3years PFS evaluated by BICR based on mRECIST.
Objective response rate (ORR) up to 3years ORR evaluated by BICR based on RECIST V1.1.
ORR up to 3years ORR evaluated by investigator based on RECIST V1.1
Serum concentration of SCT-I10A and SCT510 up to 3years Anti-drug antibody (ADA) up to 3years
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
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Trial Locations
- Locations (1)
307 Hospital of PLA
🇨🇳Beijing, Beijing, China
307 Hospital of PLA🇨🇳Beijing, Beijing, China