Clinical trial · Interventional
Comparison Between Radiofrequency Ablation and Hypofractionated Proton Beam Radiation for Recurrent/Residual HCC
A Randomized Phase III Study of the Comparison Between Radiofrequency Ablation and Hypofractionated Proton Beam Radiation in Patients With Recurrent/Residual Small Hepatocellular Carcinoma (APROH Study)
NCT01963429CI-TRIAL-00047517completedN/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 phase 3 study is to evaluate the effectiveness of the comparison between radiofrequency ablation and hypofractionated proton beam radiation.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Small Hepatocellular Carcinoma | Small Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
| Residual Small Hepatocellular Carcinoma | Small Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proton beam therapy | Radiation | — | UNRESOLVED |
| radiofrequency ablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A(radiofrequency ablation )
- description
- radiofrequency ablation
- interventionNames
- Procedure: radiofrequency ablation
- type
- EXPERIMENTAL
- label
- B(Proton)
- description
- hypofractionated proton beam therapy
- interventionNames
- Radiation: Proton beam therapy
Primary outcomes (1)
- measure
- local progression-free survival(LPES)
- timeFrame
- up to 2 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * HCC diagnosed as (i) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level greater than 200 IU/ml and a radiologically compatible feature with HCC in one or more CT/MRI/angiograms, or (ii) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level less than 200 IU/ml, and a radiologically compatible feature with HCC in two or more CT/MRI/angiograms or (iii) histological confirmation * HCC patients who had recurrent or residual tumor after other treatments * without evidence of extrahepatic metastasis * the largest diameter of tumor should be less than 3cm, and the number of tumor ≤2 * no previous treatment to target tumors by other forms of RT * liver function of Child-Pugh class A or B7 (Child-Pugh score of ≤7) * Age of ≥18 years * performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) score * WBC count ≥ 2,000/mm3; hemoglobin level ≥ 7.5 g/dL; platelet count ≥ 50,000/mm3; and adequate hepatic function (total bilirubin ≤ 3.0 mg/dL; AST and ALT \< 5.0× upper limit of normal; no ascites) * no serious comorbidities other than liver cirrhosis * written informed consent Exclusion Criteria: * evidence of extrahepatic metastasis * age \< 18 years * liver function of Child-Pugh class B8-9 and C (Child-Pugh score of \>7) or uncontrolled cases of active chronic hepatitis B * previous history of other forms of RT adjacent to target tumors * poor performance status of 3 to 4 on the Eastern Cooperative Oncology Group (ECOG) score * pregnant or breast feeding status * previous history uncontrolled other malignancies within 2 years
References
Publications (1)
- DERIVEDKim TH, Koh YH, Kim BH, Kim MJ, Lee JH, Park B, Park JW. Proton beam radiotherapy vs. radiofrequency ablation for recurrent hepatocellular carcinoma: A randomized phase III trial. J Hepatol. 2021 Mar;74(3):603-612. doi: 10.1016/j.jhep.2020.09.026. Epub 2020 Oct 5. PMID 33031846