jRCTs031210114已完成不适用
Balloon-Occluded Trans-Arterial Chemo-Embolization Technique with Repeated Alternate Infusion of Cisplatin Solution and Sparse Gelatin Slurry (RAIB-TACE) for Hepatocellular Carcinoma refractory or intolerant to Atezolizumab plus Bevacizumab combination therapy
未提供0 个研究点目标入组 19 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 主要终点
- OR (CR+PR)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients with hepatocellular carcinoma diagnosed by enhanced CT or MRI
- •Hepatocellular Carcinoma refractory or intolerant to combination of atezolizumab and bevacizumab
- •Age: 20 years or older
- •ECOG Performance Status 0-1
- •Consent has been obtained from the patient.
- •The patient is expected to survive for at least 3 months after treatment.
排除标准
- •Child pugh score over 8
- •Renal failure (eGFR <40)
- •Portal vein or Hepatic vein tumor thrombus
- •More than 15cm tumor (the maximum tumor size)
- •Sarcomatous changes (over the course of 2-3 months, the tumor size increases 1.5-2 times or more in size and there is no increase in arterial blood flow. Alternatively, there is a ring of staining with irregular margins and no capsule structure and internal necrosis.
- •Lymph node involvement or distal metastasis
- •Previous surgical biliary reconstruction.
- •Dilation of bile ducts larger than the diameter of the accompanying portal vein at the level of the area or higher.
- •A severe arterial-portal or arterial-venous shunt is present.
- •Severe mental impairment.
- •Severe allergy to iodine contrast medium or cisplatin.
- •Pregnant or lactating patients.
- •Other patients who are deemed unsuitable as subjects by the investigator (or subspecialist).
- •Immune-related Adverse Events that require steroid administratin (more than 30mg/day of prednisolone)
结局指标
主要结局
OR (CR+PR)
Patient-based tumor reduction effect based on RECIST, a centrally judged hepatocellular carcinoma treatment efficacy criterion. OR (CR+PR) for all patients will be calculated.
次要结局
- Patient-based tumor reduction effect
- Survival rate(6 months)
- Percentage of patients with Child-Pugh score A(postoperatively)
- Composite endpoint of Child-Pugh score A(postoperatively)
- RAIB-TACE-induced changes in liver reserve(pre-treatment vs. 1 and 2 months after treatment)
研究者
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