KCT0006483
Recruiting
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 sites120 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- The Catholic University of Korea, Incheon St. Mary's Hospital
- Enrollment
- 120
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •?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).
Exclusion Criteria
- •?\= 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
Outcomes
Primary Outcomes
Not specified
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