Clinical trial · Interventional
SBRT Versus Ablation for Perivascular Hepatocellular Carcinoma
Stereotactic Body Radiotherapy Versus Ablation for Perivascular Hepatocellular Carcinoma: A Phase 2, Multicenter, Randomized Controlled Trial
NCT04434989CI-TRIAL-00045578SAILunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This trial is a multi-center, phase III, randomized (1:1) clinical trial. The aim is to explore the efficacy and safety of SBRT for perivascular hepatocellular carcinoma, compared with RFA.
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 | Procedure | — | UNRESOLVED |
| Stereotactic Body Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Stereotactic Body Radiation Therapy
- description
- SBRT is defined as a special radiotherapy technique. The high dose of radiotherapy is accurately injected into the tumor lesion in one to several times using external irradiation technique. Then the tumor is exposed to high dose and the surrounding normal tissue to low dose.
- interventionNames
- Radiation: Stereotactic Body Radiation Therapy
- type
- ACTIVE_COMPARATOR
- label
- Radiofrequency Ablation
- description
- Percutaneous radiofrequency ablation to the tumor
- interventionNames
- Procedure: radiofrequency ablation
Primary outcomes (2)
- measure
- 1-year local recurrence rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Primary hepatocellular carcinoma or recurrent hepatocellular carcinoma after curative treatment. 2. Unifocal tumor ≤5cm 3. Closed to great vessels (diameter ≥3mm) 4. ECOG score 0-1 5. Child-Pugh grade A or B7 6. Sufficient liver and kidney function Exclusion Criteria: 1. Vascular invasion 2. Extra-hepatic metastasis 3. Received TACE before 4. Inflammation of local skin 5. Dysfunction of liver, kidney or bone marrow. 6. Concomitant other malignant tumor or HIV infection
References
Publications (4)
- BACKGROUNDKang TW, Lim HK, Lee MW, Kim YS, Choi D, Rhim H. Perivascular versus nonperivascular small HCC treated with percutaneous RF ablation: retrospective comparison of long-term therapeutic outcomes. Radiology. 2014 Mar;270(3):888-99. doi: 10.1148/radiol.13130753. Epub 2013 Nov 22. PMID 24475820
- BACKGROUNDKim N, Cheng J, Jung I, Liang J, Shih YL, Huang WY, Kimura T, Lee VHF, Zeng ZC, Zhenggan R, Kay CS, Heo SJ, Won JY, Seong J. Stereotactic body radiation therapy vs. radiofrequency ablation in Asian patients with hepatocellular carcinoma. J Hepatol. 2020 Jul;73(1):121-129. doi: 10.1016/j.jhep.2020.03.005. Epub 2020 Mar 10. PMID 32165253
- 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
- BACKGROUNDRajyaguru DJ, Borgert AJ, Smith AL, Thomes RM, Conway PD, Halfdanarson TR, Truty MJ, Kurup AN, Go RS. Radiofrequency Ablation Versus Stereotactic Body Radiotherapy for Localized Hepatocellular Carcinoma in Nonsurgically Managed Patients: Analysis of the National Cancer Database. J Clin Oncol. 2018 Feb 20;36(6):600-608. doi: 10.1200/JCO.2017.75.3228. Epub 2018 Jan 12. PMID 29328861