KCT0006483招募中未知
Chemoembolization Combined Radiofrequency Ablation vs. Chemoembolization Alone for Treatment of beyond the Milan Criteria viable Hepatocellular Carcinoma (CERFA): A Multi-institutional, Open-label, Parallel-group, Pragmatic, Randomized Controlled Trial
The Catholic University of Korea, Incheon St. Mary's Hospital0 个研究点目标入组 120 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19?(Year) 至 90?(Year)（—）
- 性别
- All
入选标准
- •?Age > 18 y and patients with hepatocellular carcinoma (HCC) diagnosed by radiologic images with underlying chronic hepatitis B or C or cirrhosis or confirmed by pathology.
- •?Single nodular HCC: maximal size of tumor between 5- and 8-cm
- •?Multinodular HCC: largest tumor < 5 cm, total number of tumors = 3
- •?Patients with ? AND (? OR ?) and a viable HCC after 1 transcatheter arterial chemoembolization (TACE)*
- •?Liver function: Child-Pugh score = 8
- •?No portal vein invasion
- •?No metastasis
- •?Normal hematologic and renal function**
- •? Performance score (Eastern Cooperative Oncology Group) 0 or 1
- •* A viable HCC will be evaluated 4-6 weeks after 1st TACE with CT. Patients with a viable HCC can be participate in this study within 4 weeks of imaging study (CT after 1st TACE).
- •**Hg >8.5 g/dL, ANC>750/uL, Platelet>30,000/uL, international normalized ratio =1.5, and serum creatinine level =1.5mg/dL
排除标准
- •?= CTCAE III AE in first TACE
- •?Unfeasible location of viable HCC for RFA
- •?Uncontrolled ascites
- •?Uncontrolled Hepatic encephalopathy
- •?Recent variceal bleeding within 6 months.
- •?A prior organ transplant
- •?An active gastric or duodenal ulcer
- •?Other uncontrolled comorbidities or malignant neoplasm (Participants with complete response over 5-year can be participate in this study)
- •?Positive for Human Immunodeficiency Virus
- •?Hematologic malignancy
- •?End-stage renal disease: Participants not in hemodialysis state (eGFR < 30 ml/min), Participants with hemodialysis can be participate in this study.
- •?End-stage heart failure (the New York Heart Association: NYHA III and IV, or history of myocardiac infarction within 12 months)
- •?Brain metastasis
研究者
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