A Randomized, Open-Label, Controlled, Multicenter, Phase III Clinical Study to Compare the Efficacy and Safety of HLX10 (Anti-PD-1 Antibody) in Combination With HLX04 (Anti-VEGF Antibody) Versus Sorafenib as the First-line Treatment in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC)
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- tumor assessment
研究概览
简要总结
This study is a randomized, double-blind, multicenter, phase III clinical study to compare the efficacy and safety of HLX10 + HLX04 vs Sorafenibas as the First-line Treatment in Patients with Locally Advanced or Metastatic HCC
Eligible subjects in this study will be randomized to Arm A or Arm B at 2:1 ratio as follows:
Arm A (treatment group): HLX10 + HLX04 Arm B (control group): sorafenib Randomization is stratified by: region (Asia (excluding Japan) vs. others), HBV infection vs. HCV infection vs. no HBV or HCV infection, portal vein invasion or/and extrahepatic spread (with vs.without), and ECOG (0 vs. 1).
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
- •Volunteer to participate in the clinical study;
- •Aged ≥ 18 years and ≤ 75 years;
- •Patients with histopathologically or cytologically diagnosed locally advanced or metastatic and/or unresectable HCC , or patients with clinically diagnosed HCC according to the diagnostic criteria of the American Association for the Study of Liver Diseases (AASLD);
- •Barcelona Clinic Liver Cancer (BCLC) Stage C; or BCLC Stage B patients who are not candidates for radical surgery and/or locoregional therapy.
- •Received no prior systemic HCC treatment (including chemotherapy, treatment with sorafenib, regorafenib, lenvatinib, or other small-molecule antiangiogenic agents);
- •At least one measurable lesion by the IRRC (central radiography) as per RECIST v1.1
- •Normal major organ functions as defined
排除标准
- •Patients with known hepatobiliary cell carcinoma, mixed cell carcinoma, or fibrolamellar cell carcinoma;
- •History of hepatic encephalopathy;
- •Patients with portal hypertension complicated with upper gastrointestinal hemorrhage, or esophageal/gastric fundal varices with the red color sign, or high hemorrhage risk investigated by the investigator within 6 months before the randomization. Subjects must receive endoscopic examinations to rule out high hemorrhage risk (e.g. red color sign and severe varices) before enrollment.
- •Patients with portal vein invasion at the main portal branch (Vp4), inferior vena cava involvement, or right cardiac involvement of HCC based on imaging examination. Patients with portal vein invasion at the main portal branch but with unobstructed blood flow in the bilateral or unilateral branch can be enrolled;
- •Central nervous system (CNS) or leptomeningeal metastases;
- •Positive for both HBV-DNA and HCV-RNA;
研究组 & 干预措施
A (treatment group)
HLX10 in combination with HLX04
干预措施: HLX10 (Drug)
A (treatment group)
HLX10 in combination with HLX04
干预措施: HLX04 (Drug)
B (control group)
sorafenib
干预措施: Sorafenib (Drug)
结局指标
主要结局
tumor assessment
时间窗: Baseline until disease progression or death, whichever occurs first (up to approximately 12 months)
Progression-free survival (PFS) (assessed by the independent radiology review committee \[IRRC\] based on Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1)
次要结局
未报告次要终点