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临床试验/JPRN-jRCTs031210114
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

发起方
Hasegawa Naoyuki

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