Accepted for/Published in: JMIR Research Protocols
Date Submitted: Nov 15, 2019
Open Peer Review Period: Nov 15, 2019 - Dec 12, 2019
Date Accepted: Jan 7, 2020
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Adjuvant α-fetoprotein-derived peptide after transarterial chemoembolization in patients with hepatocellular carcinoma: safety trial
ABSTRACT
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).
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