JPRN-jRCT1032200036招募中2 期
Multi-center clinical trial of a Carbon-ion radiation therapy for unresectable and local therapy unsuitable hepatocellular carcinoma
Ohno Tatsuya0 个研究点目标入组 130 人开始时间: 2020年5月22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
- 130
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) Histologically or clinically diagnosed primary hepatocellular carcinoma.
- •2) Untreated and absence of previous local therapy.
- •3) Solitary tumor without extrahepatic lesions.
- •4) The tumor is measurable and tumor size is less than 12 cm.
- •5) Absence of major portal vein and/or hepatic vein.
- •6) The tumor is in contact with the alimentary tract.
- •7) Unfit for resection or liver transplantation.
- •8) Unfit for percutaneous tumor ablation.
- •9) ECOG PS: 0-2.
- •10) Child-Pugh score of the patient is from 5 points to 9 points.
- •11) Absence of uncontrolled ascites and/or pleural effusion.
- •12) 20-year-old or older.
- •13) The patient is able to understand the explanation of the clinical trial and written informed concent is obtained.
排除标准
- •1) Patients with any other active malignancies.
- •2) Having esophageal varices which are at great risk of bleeding
- •3) Having active infectious diseases
- •4) Having a fever greater than 38 degrees Celsius.
- •5) Having myocardial infarction or angina pectoris within 6 months.
- •6) Having interstitial pneumonitis, pulmonary fibrosis or severe respiratory disease such as pulmonary emphysema.
- •7) Having radiation hypersensitivity.
- •8) Associated with mental illness or manifestation complicating study participation.
- •9) Being pregnant or possible conception.
- •10) Miscellaneous inappropriate conditions judged by physicians.
研究者
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