NCT06196775尚未招募2 期
A Single-arm, Single-center, Phase II Clinical Trial of Cadonilimab (Anti PD-1/CTLA-4) Combined With AK112 (Anti VEGF/PD-1) as Second-line Therapy in Patients With Unresectable Locally Advanced, Recurrent or Metastatic Hepatocellular Carcinoma
Harbin Medical University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年1月31日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Progression-Free-Survival
研究概览
简要总结
To evaluate the efficacy and safety of cadonilimab combined with AK112 as second-line therapy in patients with advanced hepatocellular carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histopathologically confirmed HCC
- •Age 18-75 years old
- •ECOG PS 0-1
- •Child Pugh A-B7
- •Patients who progressed on first-line standard system therapy (immunotherapy combined with Anti-angiogenesis targeting regimen) or with intolerable toxicity
- •At least one measurable lesion (RECIST 1.1)
- •Enough organ and bone marrow function
- •Expected survival time≥12 weeks
- •Sign a written informed consent and be able to comply with the visit and related procedures required by the study protocol
排除标准
- •Severe complications due to primary liver disease
- •No prior systemic therapy for advanced or metastatic primary hepatocellular carcinoma
- •Malignant diseases other than primary hepatocellular carcinoma were diagnosed within 5 years prior to first administration
- •Previous treatment with drugs that synergistically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137)
- •Autoimmune immune disease
- •History of HIV
- •Prognent women
- •The presence of any serious or uncontrolled systemic disease
- •Medical history or evidence of disease that may interfere with the test results, prevent participants from participating fully in the study, abnormal treatment or laboratory test values, or other conditions that the investigator considers unsuitable for enrollment. The Investigator considers that there are other potential risks that are not suitable for participation in the study.
结局指标
主要结局
Progression-Free-Survival
时间窗: From the first drug administration up to two years
Defined as the time between signing the informed consent form to the disease progression (according to RECIST v1.1 criteria) or death due to any cause.
次要结局
- Objective Response Rate(From the first drug administration up to two years)
- Incidence of Adverse Events(From the first drug administration to within 90 days for the last dose)
- Disease control Rate(From the first drug administration up to two years)
- Overall survival(From the first drug administration up to two years)
研究者
Yanqiao Zhang
Director
Harbin Medical University
研究点 (1)
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