A Multi-center, Randomized, Controlled, Open-label Phase II/III Clinical Trial to Investigate Whether Transarterial Tirapazamine Injection Followed by Transarterial Embolization (TATE) is Superior to Traditional Transarterial Chemoembolization (TACE) in Patients With Intermediate-Stage Hepatocellular Carcinoma (HCC)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This phase I/II clinical trial aims to determine the efficacy and safety of TATE compared to TACE in patients with intermediate-stage HCC. The results will provide valuable insights into the potential benefits of TATE as a novel treatment option for 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
- Single (Outcomes Assessor)
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
- •Patients diagnosed with primary hepatocellular carcinoma according to AASLD criteria.
- •No evidence of extrahepatic metastasis, regional lymph node involvement, or vascular tumor thrombus.
- •Patients must be eligible for TAE or TACE treatment.
- •Child-Pugh score ≤
- •Adequate bone marrow, liver, and kidney function is required.
排除标准
- •History of liver transplantation.
- •Previous radioemblization or radiotherapy for liver tumors.
- •severe cardiovascular or renal diseases, active systemic infections.
- •Clinically significant hypoxia (oxygen saturation < 92% without oxygen supplementation)
研究组 & 干预措施
TACE
Patients will receive cTACE with a mixture of iodized oil （10mL）and epirubicin (50 mg ), followed by embolization with gelatin sponge and contrast agent suspension.
干预措施: TACE (Procedure)
TATE
Patients will receive a fixed dose of 35 mg tirapazamine via hepatic arterial injection, followed by embolization with iodized oil, gelatin sponge and contrast agent suspension.
干预措施: tirapazamine (Drug)
TATE
Patients will receive a fixed dose of 35 mg tirapazamine via hepatic arterial injection, followed by embolization with iodized oil, gelatin sponge and contrast agent suspension.
干预措施: Transarterial Embolization (TAE) (Procedure)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: 36 months
Progression-free survival (PFS) assessed by the Independent Radiology Committee (IRC) using mRECIST criteria.
次要结局
- Complete Response (CR) rate(36 months)
- objective response rate (ORR)(36 months)
- duration of complete response (DOCR)(36 months)
- overall survival (OS)(36 months)