NCT06707233招募中2 期
Y-90 Selective Internal Radiation Therapy for Unresectable Hepatocellular Carcinoma Larger Than 7cm: a Prospective, Single Arm Trial
Second Affiliated Hospital of Guangzhou Medical University2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2024年12月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Objective response rate (ORR) per mRECIST
研究概览
简要总结
This is a phase II clinical study to evaluate the efficacy and safety of SIRT in patients with HCC greater than 7 cm. After enrollment, patients received yttrium-90 selective internal radiation therapy. The primary endpoint of the study is objective reponse rate (ORR) as assessed by mRECIST. Secondary endpoints were: objective response rate (ORR) as assessed by RECIST 1.1, disease control rate (DCR), progression-free survival (PFS), time to response (TTR), duration of response (DOR), overall survival (OS), and safety (incidence and severity of adverse events).
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
- •Pathologically confirmed or clinically diagnosed HCC
- •Unresectable HCC as assessed by a team of surgeons
- •The largest tumor size > 7 cm
- •Tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment
- •At least one measurable intrahepatic target lesion
- •Appropriate for SIRT treatment after evaluation (including SPECT/CT evaluation after arterial perfusion with 99Tc-MAA)
- •Child-Pugh score ≤ 7
- •ECOG PS ≤ 1
- •Adequate organ and hematologic function with platelet count ≥75×10^9/L, leukocyte >3.0×10^9/L, Neutrophil count ≥1.5×10^9/L, haemoglobin ≥85 g/L, ALT and AST≤5×ULN, creatinine≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds
- •life expectancy of at least 6 months
排除标准
- •Macrovascular invasion or extrahepatic metastasis
- •Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy
- •Organ (heart and kidneys) dysfunction
- •History of other malignancies
- •Uncontrollable infection
- •History of organ or cells transplantation
- •History of HIV
- •Pregnant or lactating patients
结局指标
主要结局
Objective response rate (ORR) per mRECIST
时间窗: 3 years
The proportion of patients with the best response of complete response (CR) or partial response (PR) according to mRECIST
次要结局
- Objective response rate (ORR) per RECIST 1.1(3 years)
- Disease control rate (DCR)(3 years)
- Progression free survival (PFS)(3 years)
- time to response (TTR)(3 years)
- Duration of response (DOR)(3 years)
- Overall survival (OS)(4 years)
- Adverse Events (AEs)(3 years)
研究者
研究点 (2)
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