NCT04560894进行中（未招募）2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 405
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Adequate hematologic and organ function.
排除标准
- •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.
研究组 & 干预措施
SCT-I10A+SCT510
Experimental
干预措施: SCT-I10A (Drug)
SCT-I10A+SCT510
Experimental
干预措施: SCT510 (Drug)
Sorafenib
Active Comparator
干预措施: Sorafenib 200mg (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: up to 3years
Progression-free survival(PFS)evaluated by the Blinded Independent Central Review Committee (BICR) based on RECIST V1.1
时间窗: up to 3years
次要结局
- PFS(up to 3years)
- Objective response rate (ORR)(up to 3years)
- ORR(up to 3years)
- Serum concentration of SCT-I10A and SCT510(up to 3years)
- Anti-drug antibody (ADA)(up to 3years)
研究者
研究点 (1)
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