Phase 2
N=54
Stereotactic Body Radiation Therapy (SBRT) Versus Trans-Arterial Chemoembolization (TACE) as Bridge to Liver Transplant
Hepatocellular Carcinoma · HCC
Bottom Line
View on ClinicalTrials.gov: NCT02182687 ↗Enrolled (actual)
54
Serious AEs
4.2%
Results posted
Mar 2024
Primary outcome: Primary: Freedom From Progression Over Time — 0; 3.4; 0; 26.5 percentage of patients with progression
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Stereotactic Body Radiation Therapy (SBRT) (Radiation); Trans-Arterial Chemoembolization (TACE) (Procedure); Doxorubin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lahey Clinic
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Freedom From Progression Over Time |
0; 3.4; 0; 26.5; 11.1; 38.0 | — |
| SECONDARY Toxicity To Compare Participants With Treatment-related Adverse Events as Assessed by CTCAE |
1; 3 | — |
| SECONDARY Number of Participants Who Require Further Interventions Prior to Liver Transplant |
1; 6 | — |
| SECONDARY Pathologic Response of Treated Lesion(s) |
15; 20; 4; 7; 6; 8 | — |
| SECONDARY Radiologic Response of Treat Lesion(s) |
18; 23 | — |
| SECONDARY Quality of Life - Questionnaires Include PIQ-6 and SF-36v2 Health Survey |
50.2; 49.9; 49.7; 48.7; 53.8; 50.9 | — |
Summary
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.
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT02182687). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.