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N/A N=76 Randomized Treatment

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

Carcinoma, Hepatocellular

Enrolled (actual)
76
Serious AEs
13.5%
Results posted
May 2024
Primary outcome: Primary: Two Year Overall Survival — 65; 68 percentage of participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Transarterial Chemoembolization (Procedure); Proton Beam Radiotherapy (Radiation)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Loma Linda University
Primary completion
Jul 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Two Year Overall Survival
65; 68

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.

Eligibility Criteria

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 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00857805). 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.

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