Clinical trial · Interventional
Combination SBRT With TACE for Unresectable Hepatocellular Carcinoma
Phase II Study of Combination Stereotactic Body Radiotherapy (SBRT) With Transarterial Chemo-Embolization (TACE) for Unresectable Hepatocellular Carcinoma
NCT01020812CI-TRIAL-00023259terminatedPhase 1 / Phase 2Results postedClinicalTrials.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): enrollment was too low
Summary
Brief summary (as posted)
To determine the efficacy and toxicity of TACE combined with SBRT
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hepatobiliary Neoplasm | Hepatobiliary Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Liver Carcinoma | Liver Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SBRT | Procedure | — | UNRESOLVED |
| TACE | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stereotactic body radiotherapy (SBRT)
- description
- SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure. Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction
- interventionNames
- Procedure: TACE
- Procedure: SBRT
Primary outcomes (1)
- measure
- Freedom From Local Progression of TACE and SBRT at 12 Months
- timeFrame
- 12 months
- description
- Freedom from local progression is defined as the time from start of treatment until the first occurrence of local progression. Local progression is defined as progression in the treated lesion according to the RECIST criteria. Progression outside the treated lesion and/or death will be considered as competing risks. The data was analyzed in a competing risk model with death as a competing risk. The outcome reported is the cumulative incidence at 12 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion - * Liver tumors treatable by SBRT not to exceed 10cm in greatest axial dimension. * 800 cc of uninvolved liver * Patients may have additional hepatic lesions if they are \<3cm and can be treated with TACE or RFA. * Age \> 18 years old * Albumin \> 2.4 g/dL. * Total bilirubin \< 3 mg/dL. * INR ≤ 1.5. * Creatinine \< 2.0 mg/dL. * Confirmed hepatocellular carcinoma by one of the following: * Histopathology * Two radiographic techniques (out of US, MRI, CT, Angiography) that confirm a lesion \>2 cm with arterial hypervascularization * One radiographic technique that confirms a lesion \>2 cm with arterial hypervascularization and an elevated AFP * Hepatic lesion in patients for whom surgical resection is not possible or would not result in an opportunity for cure * Tumor(s) \<10cm * Eastern Clinical Oncology Group performance status 0, 1 or 2 * No prior surgery, chemotherapy, or radiation for the current tumor * Patients placed on the liver transplant registry are eligible for this trial, but will be withdrawn from the protocol if they receive liver transplantation. * TACE done prior to study enrollment is allowed if there were no more than 3 procedures within an 18 week period and SBRT can begin within 12 weeks of the last TACE procedure. Exclusion - * Prior radiotherapy to the upper abdomen * Prior TACE, RFA, or liver transplant * Tumor(s) ≥ 10cm * Large esophageal varices without band ligation * Active GI bleed or within 2 weeks of study enrollment * Ascites refractory to medical therapy * Contraindication to receiving radiotherapy * Women who are pregnant * Administration of any systemic cytotoxic agents within the last 12 months * Presence of extrahepatic metastases * Participation in another concurrent treatment protocol
References
Publications (0)
Data not yet available
No reference posted for this study.