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
- Conditions
- Neoplasms
- Registration Number
- KCT0006483
- Lead Sponsor
- The Catholic University of Korea, Incheon St. Mary's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
?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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete response rate by m-RECIST
- Secondary Outcome Measures
Name Time Method Progression free survival;Response rate (sum of complete and partial response rate);Number of treatments until cure;overall survival;Change of liver function (Liver function test and Child score) within 6 mo