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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiofrequency ablation with radiotherapy | Experimental | Patients in this arm will receive liver radiotherapy around the primary tumor margin within one month after radiofrequency ablation for hepatocellular carcinoma. |
|
| Radiofrequency ablation alone | Active Comparator | Patients in this arm will only receive radiofrequency ablation for hepatocellular carcinoma. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency ablation with radiotherapy | Drug | Radiofrequency ablation with radiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| the 2-years recurrence rate | Two year recurrence rate between the two groups will be compared. | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| the 2-years recurrence-free survival | Two year recurrence-free survival between the two groups will be compared. | 2 year |
| the 2-years overall survival. | Two year overall survival between the two groups will be compared. |
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Inclusion Criteria:
Clinical diagnoses of hepatocellular carcinoma based on EASL.
Tumors, either single, >2 and < 5 cm in size or no more than 3 for size < 3 cm.
Patients must have a performance status of ECOG score < 2.
Patients must have adequate liver reservation and adequate hemogram.
Patient must have serum creatinine < 1.5 mg/dl
Cardiac function with NYHA classification < Grade II
HBsAg (+) .
Signed informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhong Jian-Hong, PhD | Contact | 0771-5301253 | zhongjianhong@gxmu.edu.cn | |
| Xiang Bang-De, PhD | Contact | 0771-5301253 | xiangbangde@gxmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Tang Wei-Zhong, PhD | Guangxi Medical University | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26628466 | Background | Wahl 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. | |
| 27709795 | Background | Seo 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. |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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Radiofrequency Ablation with or without Radiotherapy
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Outcomes (recurrence or death) Assessor is blind about the interventions.
| Radiofrequency ablation alone | Drug | Radiofrequency ablation without radiotherapy |
|
| 2 year |
| 30805950 | Background | Hara 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. |
| 30773192 | Background | Kim 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. |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |