jRCTs031200334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 the Patients with Hepatocellular Carcinoma beyond Up-to 7 Criteria (RAIB-TACE for the Patients with Hepatocellular Carcinoma beyond Up-to 7 Criteria)
未提供0 个研究点目标入组 19 人开始时间: 2021年3月3日最近更新:
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
- Patient-based tumor reduction effect
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
- •Up to seven criteria out
- •need to treat two or more subsegmenta by TACE
- •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 is greater than or equal to
- •Renal function with an eGFR of less than
- •Tumor throat in portal vein branch or main stem or hepatic vein.
- •The largest tumor is greater than or equal to 15 cm in diameter.
- •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 distant metastasis.
- •Previous surgical biliary reconstruction or endoscopic bile duct treatment.
- •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 other drugs.
- •Pregnant or lactating patients.
- •Other patients who are deemed unsuitable as subjects by the investigator (or subspecialist).
- •Previous radiation therapy for hepatocellular carcinoma.
结局指标
主要结局
Patient-based tumor reduction effect
Based on RECICL, a centrally judged hepatocellular carcinoma treatment efficacy criterion
OR (CR+PR)
Objective response rate (complete response + partial response) for all patients
次要结局
- Patient-based tumor reduction effect
- Percentage of patients with Child-Pugh score A postoperatively
- Composite endpoint of OR for Child-Pugh score A postoperatively
- OR (CR+PR) based on RECICLE and mRECIST
- RAIB-TACE-induced changes in liver reserve(1 and 2 months after treatment)
研究者
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