NCT06618664招募中3 期
A Randomized, Controlled, Open-label, Multicenter Phase III Clinical Study of Anti CTLA-4 Antibody SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab or Atezolizumab Combined With Bevacizumab for the First-line Treatment of Advanced Hepatocellular Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 590
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
THis study aims to evaluate the efficacy of SHR-8068 combined with Adebrelimab and Bevacizumab compared with Sintilimab or Atezolizumab combined with Bevacizumab for the first-line treatment of advanced HCC.
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
- •Able and willing to provide a written informed consent.
- •≥ 18 years old, both male and female.
- •Unresectable locally advanced or metastatic HCC confirmed by histopathologically/cytologically.
- •At least one measurable lesion based on RECIST v1.1 criteria.
- •Barcelona clinic liver cancer: Stage B or C.
- •No previous systemic antitumor therapy for HCC.
- •ECOG PS of 0-
- •Child-Pugh score of A or B
- •Expected survival period ≥ 12 weeks.
- •Adequate organ function.
- •Blood pregnancy negative (women of childbearing age) and non-breastfeeding, effective contraception.
排除标准
- •Hepatic cholangiocarcinoma, mixed hepatocellular carcinoma -cholangiocarcinoma, sarcomatoid hepatocellular carcinoma and fibrolamellar hepatocellular carcinoma.
- •Patients with other malignancies currently or within the past 5 years.
- •With known severe allergic reactions to any other monoclonal antibodies.
- •Patients with known CNS metastasis or hepatic encephalopathy.
- •Patients with liver tumor burden greater than 50% of total liver in volume or received liver transplants.
- •Patients with symptomatic ascites or pleural effusion.
- •Patients with hypertension which cannot be well controlled by antihypertensives.
- •Uncontrolled cardiac diseases or symptoms.
- •Known hereditary or acquired bleeding (e.g., coagulopathy) or a tendency to clot (e.g., hemophiliacs).
- •Major vascular disease occurred in the 6 months before randomization.
- •Gastrointestinal perforation or gastrointestinal fistula within 6 months before randomization.
- •Major surgery within 28 days before randomization or expected to require major surgery during the study period.
- •Active infection, or fever of unknown cause ≥ 38.5℃ in the first 7 days of randomization, or WBC > 15×109/L at baseline.
- •Known positive history of human immunodeficiency virus test or acquired immunodeficiency syndrome, known HBV infection, known HCV infection.
- •Patients who received live vaccines within 28 days before randomization, or are expected to be vaccinated during the treatment period
- •Patients with other potential factors that may affect the study results.
研究组 & 干预措施
Sintilimab combined with Bevacizumab or Atezolizumab
Active Comparator
干预措施: Atezolizumab injection (Drug)
Sintilimab combined with Bevacizumab or Atezolizumab
Active Comparator
干预措施: Sintilimab (Drug)
Sintilimab combined with Bevacizumab or Atezolizumab
Active Comparator
干预措施: Bevacizumab (Drug)
SHR-8068 combined with Adebrelimab and Bevacizumab
Experimental
干预措施: SHR-8068 (Drug)
SHR-8068 combined with Adebrelimab and Bevacizumab
Experimental
干预措施: Bevacizumab (Drug)
SHR-8068 combined with Adebrelimab and Bevacizumab
Experimental
干预措施: Adebrelimab (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: From Randomization to the first occurrence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or initiation of new anti-tumor therapy (up to approximately 36 months)
Progression Free Survival (PFS)
时间窗: From Randomization to the first occurrence of disease progression as determined by the Blinded Independ Review Committee (BIRC) according to RECIST v1.1 or initiation of new anti-tumor therapy (up to approximately 36 months)
Overall survival (OS)
时间窗: From randomization to death from any cause (whichever occurs first) (up to approximately 36 months)
OS is defined as the time from randomization to death from any cause.
次要结局
- Time to Progression (TTP)(From randomization to the first occurrence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 (up to approximately 36 months)])
- Disease Control Rate (DCR)(From Randomization to the first occurrence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or initiation of new anti-tumor therapy (up to approximately 36 months))
- Duration of Response (DoR)(From the first occurrence of a confirmed objective response to disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or death from any cause (whichever occurs first) (up to approximately 36 months))
- Time to Response (TTR)(From the first occurrence of complete response (CR) or partial response (PR) as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 (up to approximately 36 months))
- Objective Response Rate (ORR)(From Randomization to the first occurrence of disease progression or initiation of new anti-tumor therapy (up to approximately 36 months))
- Time to Progression (TTP)(From randomization to the first occurrence of disease progression as determined by the Blinded Independ Review Committee (BIRC) according to RECIST v1.1 (up to approximately 36 months)])
- Disease Control Rate (DCR)(From Randomization to the first occurrence of disease progression as determined by the Blinded Independ Review Committee (BIRC) according to RECIST v1.1 or initiation of new anti-tumor therapy (up to approximately 36 months))
- Duration of Response (DoR)(From the first occurrence of a confirmed objective response to disease progression as determined by the Blinded Independ Review Committee (BIRC) according to RECIST v1.1 or death from any cause (whichever occurs first) (up to approximately 36 months))
- Time to Response (TTR)(From the first occurrence of complete response (CR) or partial response (PR) as determined by the Blinded Independ Review Committee (BIRC) according to RECIST v1.1 (up to approximately 36 months))
- The incidence, severity and relevance to investigational drugs of adverse events (AE) and serious adverse events (SAE) according to NCI-CTCAE v5.0(From the ICF date until the end of the safety follow-up or initiation of new anti-tumor therapy (up to approximately 36 months))
研究者
研究点 (1)
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