Transarterial Chemoembolization Versus Proton Beam Radiotherapy for the Treatment of Hepatocellular Carcinoma

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Controlled Trial of Transarterial Chemoembolization Versus Proton Beam Radiotherapy for the Treatment of Hepatocellular Carcinoma

Conditions
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Carcinoma, Hepatocellular

Intervention / Treatment
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* Procedure: Transarterial Chemoembolization
* Radiation: Proton Beam Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients are candidates to receive both proton beam and TACE Patients with no evidence of metastasis or macrovascular invasion Patients with tumor burden that meets San Francisco criteria Exclusion Criteria: Patients who are candidates for surgical resection Patients with lesion < 2 cm Patients who have contraindication to receive either TACE or proton Patients with serum alpha fetoprotein > 500 Patients with metastasis or macrovascular invasion Patients treated previously for HCC by any locoregional treatment Patients with prior liver transplant Patients with Child class C Patients with MELD score of > 25 Patients with other comorbid diseases that may impact survival Patients with ongoing alcohol intake Patients with active sepsis Patients with gastrointestinal bleeding within a week Patients unwilling to sign informed consent form Patients with history of noncompliance

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transarterial Chemoembolization<br>Transarterial Chemoembolization | Procedure: Transarterial Chemoembolization<br>* Application of carboplatin, doxorubicin in ethiodol into the artery for one or more sessions.<br>* Other names: (TACE);|
| Active Comparator: Proton Beam Radiotherapy<br>Proton Beam Radiotherapy | Radiation: Proton Beam Radiotherapy<br>* Fifteen consecutive sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | lifetime | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  | Lifetime | 
| Downstaging |  | Lifetime | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transarterial chemoembolization, Carcinoma, Hepatocellular, Proton Beam Radiotherapy