NCT07150377尚未招募2 期
A Phase II Single-Arm Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Lenvatinib and TACE for Advanced Hepatocellular Carcinoma
The Second Affiliated Hospital of Shandong First Medical University0 个研究点目标入组 41 人开始时间: 2025年8月24日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 41
- 主要终点
- PFS
研究概览
简要总结
To evaluate the efficacy of Iparomlimab and Tuvonralimab in combination with Lenvatinib and TACE for advanced hepatocellular carcinoma by assessing Progression-Free Survival (PFS).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First-line Cohort:
- •Confirmed diagnosis of hepatocellular carcinoma (HCC), aged > 18 years. No prior systemic therapy.
- •Child-Pugh class A/B at baseline.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment.
- •Measurable lesions per modified Response Evaluation Criteria in Solid Tumors (mRECIST).
- •Adequate organ and bone marrow function.
- •Second-line Cohort:
- •Confirmed diagnosis of HCC, aged > 18 years.
- •Prior first-line therapy (including targeted therapy or immunotherapy).
- •Child-Pugh class A/B at baseline.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment.
- •Measurable lesions per modified Response Evaluation Criteria in Solid Tumors (mRECIST).
- •Adequate organ and bone marrow function.
排除标准
- •Concomitant hepatic encephalopathy.
- •History of any nephrotic syndrome.
- •History of clinically significant cardiovascular disease or arterial thromboembolic events, including stroke, myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within 6 months prior to randomization.
- •Evidence of any prior or current coagulopathy or bleeding diathesis, or any type of surgery performed within the past 28 days (biopsy is not excluded).
- •History of abdominal fistula, gastrointestinal perforation, refractory non-healing gastric ulcer, or active gastrointestinal bleeding within 6 months prior to randomization.
- •Main portal vein thrombosis visible on baseline imaging.
- •Pleural or peritoneal effusion requiring clinical intervention.
- •Gastroesophageal varices.
- •Portal vein invasion (VP3 or VP4).
研究组 & 干预措施
Iparomlimab and Tuvonralimab in combination with Lenvatinib and TACE for advanced hepatocellular car
Experimental
干预措施: First-line Cohort (Drug)
Iparomlimab and Tuvonralimab in combination with Lenvatinib and TACE for advanced hepatocellular car
Experimental
干预措施: Second-line Cohort (Drug)
结局指标
主要结局
PFS
时间窗: 1 year
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse
次要结局
- OS(2 years)
- Objective Response Rate(1 year)
- Adverse Events(2 years)
研究者
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