Clinical trial · Interventional
Comparing Re-TACE Versus SABR for Post-prior-TACE Incompletely Regressed HCC: a Randomized Controlled Trial (TASABR)
Comparing Re-trans-catheter Arterial Chemoembolization Versus Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma Patients Who Had Incomplete Response After Prior TACE (TASABR Trial): a Randomized Controlled Trial
NCT02921139CI-TRIAL-00053575TASABRunknownN/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)
Till now, trans-arterial chemoembolization (TACE) is still one of the common modalities in treating hepatocellular carcinoma patients with unresectable intermediate stage. However, residual viable HCC after TACE is not uncommon, leading to a poor overall survival after TACE alone. Recently, stereotactic ablative radiotherapy (SABR) has been reported to be potentially useful for curatively managing early-stage HCC in retrospective studies. Thus, conducting a randomized clinical trial to test the role of SABR in eradicating post-TACE residual tumors is therefore encouraged. The present phase-III trial intended to compare clinical outcomes between TACE + SABR and TACE + re-TACE for HCC patients with post-prior-TACE residual tumors.
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(HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Re-Transcatheter arterial chemoembolization (re-TACE) | Procedure | — | UNRESOLVED |
| Stereotactic ablative radiotherapy (SABR) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Stereotactic ablative radiotherapy (SABR)
- interventionNames
- Radiation: Stereotactic ablative radiotherapy (SABR)
- type
- ACTIVE_COMPARATOR
- label
- Arm II
- description
- Re-transcatheter arterial chemoembolization (re-TACE)
- interventionNames
- Procedure: Re-Transcatheter arterial chemoembolization (re-TACE)
Primary outcomes (1)
- measure
- freedom form local progression
- timeFrame
- Up to 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Patient has a) Radiographic enhancing liver lesions with early enhance and delay wash out on triple phase CT or MRI or b) histological confirmation of HCC as determined by the Liver Tumor Board * Age ≧ 20 * Genders: Both male and female * Barcelona Clinic Liver Cancer (BCLC) stage A to B * Child-Pugh A or B * Unresectable tumors or medically inoperable status or surgery was declined/refused. * Meets clinical criteria for eligibility for TACE or SABR * SABR can be applied within 6 weeks of registration * Eastern Cooperative Oncology Group (ECOG) 0 or 1 * Life expectancy \> 12 weeks * negative pregnancy * No prior treatment, except for surgical resection and radiofrequency ablation (RFA) * Lab ： 1. Hemoglobin ≧ 8.0 g/dL(may be post-transfusion if clinically indicated) 2. Total bilirubin ≦ 3.0 mg/dL 3. Aspartate aminotransferase (AST) ≦ 5x institutional upper limit of normal 4. Alanine transaminase (ALT) ≦ 5x institutional upper limit of normal 5. Absolute neutrophil count ≧ 1,000 /μl 6. Platelet count ≧ 20,000/μl (may be post-transfusion if clinically indicated) 7. Prothrombin time-international normalized ratio ≤ 1.7 Exclusion Criteria: * Previous TACE ≥ 2 times * Prior radiotherapy to the upper abdomen * Prior invasive malignancy other than primary liver malignancy (except non-melanomatous skin cancer) unless disease free for at least 3 years * metastatic disease * cardiac ischemia or stroke within last 6 months * medical or psychosocial condition unsuitable * History of sorafenib therapy within 21 days prior
References
Publications (7)
- BACKGROUNDChang IC, Huang SF, Chen PJ, Chen CL, Chen CL, Wu CC, Tsai CC, Lee PH, Chen MF, Lee CM, Yu HC, Lo GH, Yeh CT, Hong CC, Eng HL, Wang J, Tseng HH, Hsiao CH, Wu HI, Yen TC, Liaw YF. The Hepatitis Viral Status in Patients With Hepatocellular Carcinoma: a Study of 3843 Patients From Taiwan Liver Cancer Network. Medicine (Baltimore). 2016 Apr;95(15):e3284. doi: 10.1097/MD.0000000000003284. PMID 27082566
- BACKGROUNDCheng X, Sun P, Hu QG, Song ZF, Xiong J, Zheng QC. Transarterial (chemo)embolization for curative resection of hepatocellular carcinoma: a systematic review and meta-analyses. J Cancer Res Clin Oncol. 2014 Jul;140(7):1159-70. doi: 10.1007/s00432-014-1677-4. Epub 2014 Apr 22. PMID 24752339
- BACKGROUNDHuo YR, Eslick GD. Transcatheter Arterial Chemoembolization Plus Radiotherapy Compared With Chemoembolization Alone for Hepatocellular Carcinoma: A Systematic Review and Meta-analysis. JAMA Oncol. 2015 Sep;1(6):756-65. doi: 10.1001/jamaoncol.2015.2189. PMID 26182200
- BACKGROUNDKang JK, Kim MS, Cho CK, Yang KM, Yoo HJ, Kim JH, Bae SH, Jung DH, Kim KB, Lee DH, Han CJ, Kim J, Park SC, Kim YH. Stereotactic body radiation therapy for inoperable hepatocellular carcinoma as a local salvage treatment after incomplete transarterial chemoembolization. Cancer. 2012 Nov 1;118(21):5424-31. doi: 10.1002/cncr.27533. Epub 2012 May 8. PMID 22570179
- BACKGROUNDTakeda A, Sanuki N, Tsurugai Y, Iwabuchi S, Matsunaga K, Ebinuma H, Imajo K, Aoki Y, Saito H, Kunieda E. Phase 2 study of stereotactic body radiotherapy and optional transarterial chemoembolization for solitary hepatocellular carcinoma not amenable to resection and radiofrequency ablation. Cancer. 2016 Jul 1;122(13):2041-9. doi: 10.1002/cncr.30008. Epub 2016 Apr 8. PMID 27062278
- 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.