JPRN-jRCTs031210114招募中2 期
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
Hasegawa Naoyuki0 个研究点目标入组 19 人开始时间: 2021年5月26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
- 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. Hepatocellular Carcinoma refractory or intolerant to combination of atezolizumab and bevacizumab
- •3. Age: 20 years or older
- •4. ECOG Performance Status 0-1
- •5. Consent has been obtained from the patient.
- •6. The patient is expected to survive for at least 3 months after treatment.
排除标准
- •1. Child pugh score over 8
- •2. Renal failure (eGFR <40)
- •3. Portal vein or Hepatic vein tumor thrombus
- •4. More than 15cm tumor (the maximum tumor size)
- •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 distal metastasis
- •7. Previous surgical biliary reconstruction.
- •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 cisplatin.
- •12. Pregnant or lactating patients.
- •13. Other patients who are deemed unsuitable as subjects by the investigator (or subspecialist).
- •14. Immune-related Adverse Events that require steroid administratin (more than 30mg/day of prednisolone)
研究者
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