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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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0006483
Enrollment
120
Registered
2021-08-20
Start date
2021-11-23
Completion date
Unknown
Last updated
2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : Eligible patients: Patients with beyond-the-Milan stage HCCs and a viable portion after 1st TACE After 4-6 weeks of 1st. TACE, participants will be randomly allocated to both contr

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion 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 8.5 g/dL, ANC>750/uL, Platelet>30,000/uL, international normalized ratio =1.5, and serum creatinine level =1.5mg/dL

Exclusion criteria

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 ? 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

Design outcomes

Primary

MeasureTime frame
Complete response rate by m-RECIST—

Secondary

MeasureTime frame
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—

Countries

Korea, Republic of

Contacts

Public ContactDong Jae Shim

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

inharad@naver.com+82-32-280-6742

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 11, 2026