Clinical trial · Interventional
Stereotactic Body Radiation Therapy (SBRT) Versus Trans-Arterial Chemoembolization (TACE) as Bridge to Liver Transplant
A Randomized Phase II Study of Individualized Stereotactic Body Radiation Therapy (SBRT) Versus Trans-Arterial Chemoembolization (TACE) With DEBDOX Beads as a Bridge to Transplant in Hepatocellular Carcinoma.
NCT02182687CI-TRIAL-00074675SBRTvsTACEcompletedPhase 2Results postedClinicalTrials.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 study will compare stereotactic body radiation therapy (SBRT) to trans-arterial chemoembolization (TACE) as a bridging strategy for patients with HCC undergoing orthotopic liver transplantation. We propose that SBRT will be associated with longer time intervals between initial treatment and the need for retreatment, compared to TACE, as a "bridge" to orthotopic liver transplantation.
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 |
|---|---|---|---|
| HCC | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxorubin | Drug | — | UNRESOLVED |
| Stereotactic Body Radiation Therapy (SBRT) | Radiation | — | UNRESOLVED |
| Trans-Arterial Chemoembolization (TACE) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Arm A
- description
- Stereotactic Body Radiation Therapy (SBRT)
- interventionNames
- Radiation: Stereotactic Body Radiation Therapy (SBRT)
- type
- OTHER
- label
- Arm B
- description
- Trans-Arterial Chemoembolization (TACE) Drug: Doxorubin
- interventionNames
- Procedure: Trans-Arterial Chemoembolization (TACE)
- Drug: Doxorubin
Primary outcomes (1)
- measure
- Freedom From Progression Over Time
- timeFrame
- 3, 6 and 12 Months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Patients with hepatocellular carcinoma are eligible for this trial. Hepatocellular carcinoma is defined as having at least one of the following: Biopsy proven hepatocellular carcinoma (HCC); or A discrete hepatic tumor(s) as defined by the Barcelona (29) criteria for cirrhotic patients, \>2cm with arterial hypervascularity and venous or delayed phase washout on CT or MRI. * Patient is within Milan Criteria and "listed" for orthotopic liver transplantation. * Patients must have a Zubrod performance status of ≤2. * Patients must have a life expectancy of at least 12 weeks. * Patients must be 18 years of age or older. Adult patients of all ages, both sexes and all races will be included in this study. * Patients must be Child-Turcotte-Pugh (CTP) Class A or Class B (≤ 7). * Female patients within reproductive years may not be, nor become, pregnant during participation in this study. Both male and female patients within reproductive years must agree to use an effective contraceptive method during treatment. Women of childbearing age will be required to undergo a urine or serum pregnancy test to ensure they are not pregnant. * Patients must have adequate organ function within 2 weeks of enrollment. Bone marrow: Platelets ≥30,000/mm3 Renal: BUN ≤40 mg/dl; creatinine ≤2.0 mg/dl Hepatic: INR ≤ 1.5 or correctable by Vitamin K, unless anti- coagulated for another medical reason Bilirubin \< 3 mg/dl (in the absence of obstruction or pre-existing disease of the biliary tract, e.g. primary sclerosing cholangitis) Patients uninvolved liver volume will be estimated and must be \> 700ml. * Patients must sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the Lahey Hospital and Medical Center indicating that they are aware of the investigational aspects of the treatment and the potential risks. Exclusion Criteria * Patients in a "special category" designated the Public Health Service, including patients younger than 18, pregnant women, and prisoners. * Refractory ascites or ascites that requires paracentesis for management. * Patients with a solitary lesion greater than 5.0cm in size or more than 2 discrete lesions the largest greater than 3.0 cm in size. * Known allergy to intravenous iodinated contrast agents unresponsive to prednisone pre-treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.