Feasibility of High Dose PROton Therapy On Unresectable Primary Carcinoma Of Liver: Prospective Phase II Trial

  • participants needed
  • sponsor
    Samsung Medical Center
Updated on 5 December 2022
liver disease
neutrophil count
radiofrequency ablation
hepatocellular carcinoma
unresectable hepatocellular carcinoma


The standard treatment of unresectable hepatocellular carcinoma (HCC) is transarterial chemoembolization (TACE) or sorafenib. Though the TACE and the agent showed survival benefit in several randomized phase III trials, the benefit was modest.

Recently, radiotherapy (RT), especially conformal and higher dose with the advancement of RT techniques, showed favorable response rate with acceptable local control rate. Based on those promising results, RT was actively applied in HCC who are not indicated with surgery and/or radiofrequency ablation.

Many researchers reported that there is a relationship between RT dose and tumor response rate. RT dose, however, is frequently limited because the complications (like radiation induced liver disease (RILD), radiation induced gastro-duodenal toxicity, etc.) are also closely related with higher exposed RT dose.

Proton beam has characteristic depth-dose distribution contrast to photon, the "Bragg peak". The advantage of this dose distribution could be more highlighted in HCC management, because of the weakness and maintenance importance of liver function itself in HCC patients. In fact, the superior results of proton beam therapy in HCC were constantly reported in several groups as prospectively as well as retrospectively.

In this background, the investigators planned the present study to evaluate the efficacy and safety of proton beam therapy in HCC patients who are not indicated with surgery and/or radiofrequency ablation (RFA).

Condition LIVER DISEASE, LIVER DISEASE, Liver Disorders, HEPATIC NEOPLASM, Liver Cancer, Neoplasm of unspecified nature of digestive system, Digestive System Neoplasms, Proton Therapy, Liver Cancer, Liver Disorders, Digestive System Neoplasms, hepatoma, tumor liver, liver tumor, liver tumours, proton beam therapy, proton beam radiation therapy
Treatment Proton arm
Clinical Study IdentifierNCT02632864
SponsorSamsung Medical Center
Last Modified on5 December 2022

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