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: 2022年1月11日

试验速览

暂无简介。

•?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

•?= 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

发起方

The Catholic University of Korea, Incheon St. Mary's Hospital