Protocol For An Adjuvant Alpha-Fetoprotein-Derived Peptide After Transarterial Chemoembolization in Patients With Hepatocellular Carcinoma: Safety Study

Abstract

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: Hepatocellular carcinoma (HCC) is a worldwide health concern because its incidence continues to increase globally; moreover, the prognosis for patients with HCC remains poor. Transarterial chemoembolization (TACE) has been established as the standard of care for intermediate stage of HCC; however, recurrence occurs at a high rate and no agents are available to suppress this. Objective: To evaluate the safety of AFP-derived peptides for patients with HCC after TACE. Methods: This will be an open-label, single arm, multicenter study to evaluate the safety of α-fetoprotein (AFP)-derived peptides (AFP 357 and AFP 403), which contain HLA-A24-restricted CTL epitopes from tumor antigens expressed in HCC and recognized by lymphocytes in HCC patients at a high rate. Protocol treatment will consist of six courses of the subcutaneous administration of 3 mg each of AFP 357 and AFP 403. A total of 14 patients will be included in this study, the first six as a main analysis target group and eight as an extended cohort from three institutions in Japan. The primary endpoint will be the occurrence of serious adverse events (safety profile). The secondary endpoints will include time to progression, overall survival, completion rate, and adverse events. Results: We will recruit 14 HCC patients until December, 2019. We will complete the final follow-up by March, 2020. Conclusions: In this study, we will evaluate the safety profile of AFP-derived peptides for patients with HCC after TACE. We believe that this study will provide useful information and will lead to the design of a subsequent phase II trial based on the results. Clinical Trial: Japan Registry of Clinical Trials (jRCTs041180155).