Carcinoma, Hepatocellular
Conditions
Keywords
Transarterial chemoembolization, Carcinoma, Hepatocellular, Proton Beam Radiotherapy
Brief summary
Patients with liver tumor burden that exceeds Milan criteria are considered to receive one of the following locoregional treatments: transarterial chemoembolization (TACE), radiofrequency ablation (RFA), percutaneous ethanol injection and proton beam radiation (PBR). The goals of these treatments are to control tumor growth, to downstage tumor size to meet Milan criteria, and to improve survival. Patients who exceed the Milan criteria benefit from tumor downstaging as a result of treatment. Patients who meet Milan criteria benefit from tumor control to bridge them to liver transplantation. TACE is considered the most common locoregional treatment that is used to treat hepatocellular carcinoma (HCC). Proton beam radiotherapy has been used in treating HCC in a few centers across the globe. Phase I and II trials showed a satisfactory safety and efficacy results. Loma Linda University Medical Center is one of these pioneering centers that use proton beam as a treatment for HCC. This is the first randomized trial in the medical field that will compare head-to-head the efficacy of TACE versus proton beam in treating HCC patients.
Interventions
PROCEDURETransarterial Chemoembolization
Application of carboplatin, doxorubicin in ethiodol into the artery for one or more sessions.
RADIATIONProton Beam Radiotherapy
Fifteen consecutive sessions
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients are candidates to receive both proton beam and TACE 2. Patients with no evidence of metastasis or macrovascular invasion 3. Patients with tumor burden that meets San Francisco criteria
Exclusion criteria
1. Patients who are candidates for surgical resection 2. Patients with lesion \< 2 cm 3. Patients who have contraindication to receive either TACE or proton 4. Patients with serum alpha fetoprotein \> 500 5. Patients with metastasis or macrovascular invasion 6. Patients treated previously for HCC by any locoregional treatment 7. Patients with prior liver transplant 8. Patients with Child class C 9. Patients with MELD score of \> 25 10. Patients with other comorbid diseases that may impact survival 11. Patients with ongoing alcohol intake 12. Patients with active sepsis 13. Patients with gastrointestinal bleeding within a week 14. Patients unwilling to sign informed consent form 15. Patients with history of noncompliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Two Year Overall Survival | 24 Months | Comparison between arms of the percentage of patient alive 2 years following study treatment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Transarterial Chemoembolization Transarterial Chemoembolization
Transarterial Chemoembolization: Application of carboplatin, doxorubicin in ethiodol into the artery for one or more sessions. | 39 |
| Proton Beam Radiotherapy Proton Beam Radiotherapy
Proton Beam Radiotherapy: Fifteen consecutive sessions | 35 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Proton Beam Radiotherapy | Total | Transarterial Chemoembolization |
|---|---|---|---|
| Age, Customized | 61.7 years STANDARD_DEVIATION 8.51 | 60.65 years STANDARD_DEVIATION 8.83 | 59.6 years STANDARD_DEVIATION 9.15 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 35 Participants | 74 Participants | 39 Participants |
| Sex: Female, Male Female | 8 Participants | 21 Participants | 13 Participants |
| Sex: Female, Male Male | 27 Participants | 53 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 13 / 39 | 16 / 35 |
| other Total, other adverse events | 39 / 39 | 35 / 35 |
| serious Total, serious adverse events | 8 / 39 | 2 / 35 |
Outcome results
Primary
Two Year Overall Survival
Comparison between arms of the percentage of patient alive 2 years following study treatment.
Time frame: 24 Months
Population: Eligible subjects were adult patients with newly diagnosed and previously untreated HCC. All subjects had characteristic findings of HCC on contrast-enhanced magnetic resonance imaging (MRI) and/or computed tomography (CT) scanning or histologic proof with biopsy. Patients were required to have tumors that were within the Milan or San Francisco criteria, although eligibility for transplant was not required.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Transarterial Chemoembolization | Two Year Overall Survival | 65 percentage of participants |
| Proton Beam Radiotherapy | Two Year Overall Survival | 68 percentage of participants |