Clinical trial · Interventional
Radiofrequency Ablation Plus Radiotherapy for Small Hepatocellular Carcinoma
radioFrequency Ablation With or Without RadioTherapy for Small HEpatocellulaR Carcinoma: a Randomized Control Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Radiofrequency ablation (RFA) and hepatic resection are main treatments for early stage hepatocellular carcinoma. Many randomized controlled trials found these two treatments have similar short term overall survival. However, hepatic resection is associated with higher long-term overall survival. These results reveal that tumor recurrence rate after RFA is higher than that after hepatic resection. And minimal residual tumor may exist after RFA. Radiotherapy after RFA may be effective to prevent early tumor recurrence.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiofrequency ablation alone | Drug | — | UNRESOLVED |
| Radiofrequency ablation with radiotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Radiofrequency ablation with radiotherapy
- description
- Patients in this arm will receive liver radiotherapy around the primary tumor margin within one month after radiofrequency ablation for hepatocellular carcinoma.
- interventionNames
- Drug: Radiofrequency ablation with radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Radiofrequency ablation alone
- description
- Patients in this arm will only receive radiofrequency ablation for hepatocellular carcinoma.
- interventionNames
- Drug: Radiofrequency ablation alone
Primary outcomes (1)
- measure
- the 2-years recurrence rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Clinical diagnoses of hepatocellular carcinoma based on EASL. 2. Tumors, either single, \>2 and \< 5 cm in size or no more than 3 for size \< 3 cm. 3. Patients must have a performance status of ECOG score \< 2. 4. Patients must have adequate liver reservation and adequate hemogram. * Pugh-Child's Score \< 7. * The serum total bilirubin level are \< 2 mg/dl. * The prothrombin times are \< 3 sec above normal control. * The platelet are \> 75 x 109/L. 5. Patient must have serum creatinine \< 1.5 mg/dl 6. Cardiac function with NYHA classification \< Grade II 7. HBsAg (+) . 8. Signed informed consent. Exclusion Criteria: 1. HCCs with radiological evidence of macrovascular invasion or extrehepatic metastasis are not eligible. 2. Patients with other systemic diseases which required concurrent usage of glucoticosteroid or immunosuppressant agent(s) are not eligible. 3. Patients with advanced second primary malignancy are not eligible. 4. Patients with pregnancy or breast-feeding are not eligible. 5. Patients with severe cardiopulmonary diseases are not eligible. 6. Patients with clinically significant psychiatric disorder are not eligible. 7. Patients who had antineoplastic chemotherapeutic or immuno-therapeutic drugs or corticosteroids within 6 weeks of commencing the protocol are not eligible. 8. Patients who had prior antitumor therapy for HCC are not eligible. 9. Anti-HCV positive patients are not eligible.
References
Publications (4)
- BACKGROUNDWahl DR, Stenmark MH, Tao Y, Pollom EL, Caoili EM, Lawrence TS, Schipper MJ, Feng M. Outcomes After Stereotactic Body Radiotherapy or Radiofrequency Ablation for Hepatocellular Carcinoma. J Clin Oncol. 2016 Feb 10;34(5):452-9. doi: 10.1200/JCO.2015.61.4925. Epub 2015 Nov 30. PMID 26628466
- BACKGROUNDSeo YS, Kim MS, Yoo HJ, Jang WI, Paik EK, Han CJ, Lee BH. Radiofrequency ablation versus stereotactic body radiotherapy for small hepatocellular carcinoma: a Markov model-based analysis. Cancer Med. 2016 Nov;5(11):3094-3101. doi: 10.1002/cam4.893. Epub 2016 Oct 5. PMID 27709795
- BACKGROUNDHara K, Takeda A, Tsurugai Y, Saigusa Y, Sanuki N, Eriguchi T, Maeda S, Tanaka K, Numata K. Radiotherapy for Hepatocellular Carcinoma Results in Comparable Survival to Radiofrequency Ablation: A Propensity Score Analysis. Hepatology. 2019 Jun;69(6):2533-2545. doi: 10.1002/hep.30591. Epub 2019 May 2. PMID 30805950
- BACKGROUNDKim N, Kim HJ, Won JY, Kim DY, Han KH, Jung I, Seong J. Retrospective analysis of stereotactic body radiation therapy efficacy over radiofrequency ablation for hepatocellular carcinoma. Radiother Oncol. 2019 Feb;131:81-87. doi: 10.1016/j.radonc.2018.12.013. Epub 2018 Dec 31. PMID 30773192