Clinical trial · Interventional
A Trial on SBRT After Incomplete TAE or TACE Versus Exclusive TAE or TACE For Treatment of Inoperable HCC
A Randomised Phase III Trial on Stereotactic Body Radiotherapy (SBRT) After Incomplete Transcatheter Arterial Embolization (TAE) or Chemoembolization (TACE) Versus Exclusive TAE or TACE for Inoperable Hepatocellular Carcinoma (HCC)
NCT02323360CI-TRIAL-00041305terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): too slow enrollment
Summary
Brief summary (as posted)
The trial is a multicentre, prospective, randomised controlled, unblinded, parallel-group superiority trial of SBRT versus standard TAE/TACE for the curative treatment of inoperable HCC treated with a TAE/TACE incomplete cycle.
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 |
|---|---|---|---|
| SBRT | Radiation | — | UNRESOLVED |
| TACE | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Stereotactic body radiation therapy
- description
- HCC after incomplete TAE or TACE treated by SBRT
- interventionNames
- Radiation: SBRT
- type
- ACTIVE_COMPARATOR
- label
- TACE/TAE
- description
- HCC after incomplete TAE or TACE treated by a new cycle of TAE or TACE
- interventionNames
- Procedure: TACE
Primary outcomes (1)
- measure
- Local control (efficacy of SBRT in selected HCC patients with an incomplete response after TACE/TAE)
- timeFrame
- 1.5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 95 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18 years * Karnofsky index \>70% * Child-Turgotte-Pugh A or B liver score. * An initial diagnosis of primary HCC or recurrence. * A technically unresectable lesion or medically contraindicated surgery or a case in which surgery was declined. * HCC (single nodule ≤ 5 cm or max 3 nodules ≤ 3 cm) diagnosed by histology or non-invasive EASL criteria * Baseline CT or MRI and bone scan without evidence of radiologically definable major vascular invasion or extrahepatic disease * Hb \>10.5.0 g/%, WBC \>3.000 cells/mm3, platelets \>50.000 cells/mm3, bilirubin \<2 mg/dl, aspartate and alanine aminotransferase levels \<5 times upper normal limit, and prothrombin time-international normalized ratio ≤ 2; * Serum creatinine \<1.7 mg/dl * Previously incomplete TAE or TACE with radiologically defined residual disease. * Informed consent Exclusion Criteria: * Extrahepatic disease and refractory ascites. * Previous abdominal radiation therapy (RT) * Hemorrhage/bleeding event = Grade 3 within 4 weeks of enrollment in the study. * Pregnant or breastfeeding patients. * Patients with uncontrolled infections or HIV seropositive patients. * Mental conditions rendering the patient incapable to understand the nature, scope, and consequences of the study.
References
Publications (1)
- DERIVEDComito T, Loi M, Franzese C, Clerici E, Franceschini D, Badalamenti M, Teriaca MA, Rimassa L, Pedicini V, Poretti D, Solbiati LA, Torzilli G, Ceriani R, Lleo A, Aghemo A, Santoro A, Scorsetti M. Stereotactic Radiotherapy after Incomplete Transarterial (Chemo-) Embolization (TAE\TACE) versus Exclusive TAE or TACE for Treatment of Inoperable HCC: A Phase III Trial (NCT02323360). Curr Oncol. 2022 Nov 16;29(11):8802-8813. doi: 10.3390/curroncol29110692. PMID 36421345