A Prospective, Randomized, Active-Controlled, Open-Label, National Multicenter Phase II/III Registration Study of SH006 Injection Combination Therapy Versus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Progression-free Survival (PFS) (Phase II)
研究概览
简要总结
To evaluate the efficacy and safety of the combination therapy of SH006 injection in the treatment of advanced hepatocellular carcinoma
详细描述
This is an open, randomized, multicenter study aimed at evaluating the safety and efficacy of SH006 injection (15 mg/kg) in combination with bevacizumab and/or oxaliplatin/capecitabine versus regorafenib in the treatment of patients with advanced hepatocellular carcinoma
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects participate voluntarily and sign informed consent.
- •Age ≥ 18 and ≤ 75 years old, male or female.
- •Histological or clinical diagnosis of HCC.
- •Barcelona Clinic Liver Cancer stage C. BCLC stage B, not suitable for radical surgery and/or local treatment
- •Previous treatment with a drug containing an immune checkpoint inhibitor failed.
- •Child-Pugh ≤7 , no history of hepatic encephalopathy.
排除标准
- •Histologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, etc.
- •History of malignancy other than HCC within 5 years prior to the start of study treatment.
- •History of liver transplantation, or planned to receive liver transplantation.
- •Moderate or severe ascites with clinical symptoms that require drainage, uncontrolled or moderate or severe pleural and pericardical effusion.
- •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •Involvement of both the main portal vein and the left and right branches by portal vein tumor thrombus, or of both the main trunk and the superior mesenteric vein concurrently, or of inferior vena cava.
研究组 & 干预措施
Arm 1 SH006 in combination with bevacizumab and chemotherapy
干预措施: Oxaliplatin injection (Drug)
Arm 4 Regorafenib
干预措施: Regorafenib (Drug)
Arm 1 SH006 in combination with bevacizumab and chemotherapy
干预措施: SH006 (Drug)
Arm 1 SH006 in combination with bevacizumab and chemotherapy
干预措施: Bevacizumab (Drug)
Arm 1 SH006 in combination with bevacizumab and chemotherapy
干预措施: Capecitabine (Drug)
Arm 2 SH006 in combination with bevacizumab
干预措施: SH006 (Drug)
Arm 2 SH006 in combination with bevacizumab
干预措施: Bevacizumab (Drug)
Arm 3 SH006 in combination with chemotherapy
干预措施: SH006 (Drug)
Arm 3 SH006 in combination with chemotherapy
干预措施: Oxaliplatin injection (Drug)
Arm 3 SH006 in combination with chemotherapy
干预措施: Capecitabine (Drug)
结局指标
主要结局
Progression-free Survival (PFS) (Phase II)
时间窗: Up to approximately 4 years
PFS was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Incidence of Adverse Events (AEs) (Phase II)
时间窗: Up to approximately 4 years
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Overall Survival (OS) (Phase III)
时间窗: Up to approximately 4 years
OS was defined as the time from randomization to death due to any cause.
次要结局
- Objective Response Rate (ORR)(Up to approximately 4 years)
- Disease Control Rate (DCR)(Up to approximately 4 years)
- Duration of Response (DOR)(Up to approximately 4 years)
- Time to progression (TTP)(Up to approximately 4 years)