JPRN-jRCTs031200334已完成2 期
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
Hoshiai Sodai0 个研究点目标入组 19 人开始时间: 2021年1月29日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable(—)
- 性别
- All
入选标准
- •1. Patients with hepatocellular carcinoma diagnosed by enhanced CT or MRI
- •2. Up to seven criteria out
- •3. need to treat two or more subsegmenta by TACE
- •4. Age: 20 years or older.
- •5. ECOG Performance Status: 0-1
- •6) Consent has been obtained from the patient.
- •7) The patient is expected to survive for at least 3 months after treatment.
排除标准
- •1) Child-Pugh score is greater than or equal to 7.
- •2) Renal function with an eGFR of less than 40.
- •3) Tumor throat in portal vein branch or main stem or hepatic vein.
- •4) The largest tumor is greater than or equal to 15 cm in diameter.
- •5) 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.
- •6) Lymph node involvement or distant metastasis.
- •7) Previous surgical biliary reconstruction or endoscopic bile duct treatment.
- •8) Dilation of bile ducts larger than the diameter of the accompanying portal vein at the level of the area or higher.
- •9) A severe arterial-portal or arterial-venous shunt is present.
- •10) Severe mental impairment.
- •11) Severe allergy to iodine contrast medium or other drugs.
- •12) Pregnant or lactating patients.
- •13) Other patients who are deemed unsuitable as subjects by the investigator (or subspecialist).
- •14) Previous radiation therapy for hepatocellular carcinoma.
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