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      Is Open Access

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

      research-article
      Author(s): , MD, PhD 1 , , MD, PhD 2 , , MD, PhD 2 , , MD, PhD 2 , , MD, PhD 1 , , , MD, PhD 2
      Editor(s):
      Other contributor(s): (Reviewer)
      Publication date (Electronic):
      Journal: JMIR Research Protocols
      Publisher: JMIR Publications
      Keywords: hepatocellular carcinoma, alpha-fetoprotein-derived peptides, safety trial

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          Abstract

          Background

          Hepatocellular carcinoma (HCC) is a worldwide health concern because of a continued increase in cases globally; furthermore, the prognosis for patients with HCC remains poor. Transarterial chemoembolization (TACE) has been established as the standard of care for the intermediate stage of HCC; however, no therapeutic agents are available to reduce the high rate of recurrence.

          Objective

          This study aims to evaluate the safety of alpha-fetoprotein (AFP)-derived peptides for patients with HCC post-TACE.

          Methods

          This will be an open-label, single-arm, multicenter study to evaluate the safety of AFP-derived peptides (AFP 357 and AFP 403), which contain histocompatibility antigen-A24-restricted cytotoxic T lymphocyte epitopes from tumor antigens expressed in HCC and is recognized at a high rate by lymphocytes in patients with HCC. 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 6 as a main analysis target group and an additional 8 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 (efficacy profile).

          Results

          We have recruited 14 patients with HCC as of December 2019. The final follow-up will be completed by March 2020.

          Conclusions

          In this study, we will evaluate the safety profile of AFP-derived peptides for patients with HCC post-TACE. We believe that this study will provide useful information and will help to design a subsequent phase II trial based on the results.

          Trial Registration

          Japan Registry of Clinical Trials jRCTs041180155; https://jrct.niph.go.jp/latest-detail/jRCTs041180155

          International Registered Report Identifier (IRRID)

          DERR1-10.2196/17082

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          Most cited references9

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          Phase III study of sorafenib after transarterial chemoembolisation in Japanese and Korean patients with unresectable hepatocellular carcinoma.

          Masatoshi Kudo, Kazuho Imanaka, Nobuyuki Chida … (2011)
          In Japan and South Korea, transarterial chemoembolisation (TACE) is an important locoregional treatment for patients with unresectable hepatocellular carcinoma (HCC). Sorafenib, a multikinase inhibitor, has been shown effective and safe in patients with advanced HCC. This phase III trial assessed the efficacy and safety of sorafenib in Japanese and Korean patients with unresectable HCC who responded to TACE. Patients (n=458) with unresectable HCC, Child-Pugh class A cirrhosis and ≥25% tumour necrosis/shrinkage 1-3 months after 1 or 2 TACE sessions were randomised 1:1 to sorafenib 400mg bid or placebo and treated until progression/recurrence or unacceptable toxicity. Primary end-point was time to progression/recurrence (TTP). Secondary end-point was overall survival (OS). Baseline characteristics in the two groups were similar; >50% of patients started sorafenib>9 weeks after TACE. Median TTP in the sorafenib and placebo groups was 5.4 and 3.7 months, respectively (hazard ratio (HR), 0.87; 95% confidence interval (CI), 0.70-1.09; P=0.252). HR (sorafenib/placebo) for OS was 1.06 (95% CI, 0.69-1.64; P=0.790). Median daily dose of sorafenib was 386 mg, with 73% of patients having dose reductions and 91% having dose interruptions. Median administration of sorafenib and placebo was 17.1 and 20.1 weeks, respectively. No unexpected adverse events were observed. This trial, conducted prior to the reporting of registrational phase III trials, found that sorafenib did not significantly prolong TTP in patients who responded to TACE. This may have been due to delays in starting sorafenib after TACE and/or low daily sorafenib doses. Copyright © 2011 Elsevier Ltd. All rights reserved.
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            Transarterial chemoembolization for unresectable hepatocellular carcinoma: meta-analysis of randomized controlled trials.

            Pietro Andreone, Calogero Cammà, Ambrogio Orlando … (2002)
            To review the available evidence of chemoembolization for unresectable hepatocellular carcinoma (HCC). Computerized bibliographic searches with MEDLINE and CANCERLIT databases from 1980 through 2000 were supplemented with manual searches, with the keywords "hepatocellular carcinoma," "liver cell carcinoma," "randomized controlled trial [RCT]," and "chemoembolization." Studies were included if patients with unresectable HCC were enrolled and if they were RCTs in which chemoembolization was compared with nonactive treatment (five RCTs) or if different transarterial modalities of therapy (13 RCTs) were compared. Data were extracted from each RCT according to the intention-to-treat method. Five of the RCTs with a nonactive treatment arm were combined by using the random-effects model, whereas all 18 RCTs were pooled from meta-regression analysis. Chemoembolization significantly reduced the overall 2-year mortality rate (odds ratio, 0.54; 95% CI: 0.33, 0.89; P =.015) compared with nonactive treatment. Analysis of comparative RCTs helped to predict that overall mortality was significantly lower in patients treated with transarterial embolization (TAE) than in those treated with transarterial chemotherapy (odds ratio, 0.72; 95% CI: 0.53, 0.98; P =.039) and that there is no evidence that transarterial chemoembolization is more effective than TAE (odds ratio, 1.007; 95% CI: 0.79, 1.27; P =.95), which suggests that the addition of an anticancer drug did not improve the therapeutic benefit. In patients with unresectable HCC, chemoembolization significantly improved the overall 2-year survival compared with nonactive treatment, but the magnitude of the benefit is relatively small.
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              Increase in CD14+HLA-DR -/low myeloid-derived suppressor cells in hepatocellular carcinoma patients and its impact on prognosis.

              YASUNARI NAKAMOTO, Tatsuya Yamashita, Shuichi Kaneko … (2013)
              Myeloid-derived suppressor cells (MDSCs) are known as key immune regulators in various human malignancies, and it is reported that CD14(+)HLA-DR(-/low) MDSCs are increased in hepatocellular carcinoma (HCC) patients. However, the host factors that regulate the frequency and the effect on the prognosis of HCC patients are still unclear. We investigated these issues and clarified the relationships between a feature of MDSCs and host factors in HCC patients. We examined the frequency of MDSCs in 123 HCC patients, 30 chronic liver disease patients without HCC, and 13 healthy controls by flow cytometric analysis. The relationships between the clinical features and the frequency of MDSCs were analyzed. In 33 patients who received curative radiofrequency ablation (RFA) therapy, we examined the impact of MDSCs on HCC recurrence. The frequency of MDSCs in HCC patients was significantly increased. It was correlated with tumor progression, but not with the degree of liver fibrosis and inflammation. In terms of serum cytokines, the concentrations of IL-10, IL-13, and vascular endothelial growth factor were significantly correlated with the frequency of MDSCs. In HCC patients who received curative RFA therapy, the frequency of MDSCs after treatment showed various changes and was inversely correlated with recurrence-free survival time. The frequency of MDSCs is correlated with tumor progression, and this frequency after RFA is inversely correlated with the prognosis of HCC patients. Patients with a high frequency of MDSCs after RFA should be closely followed and the inhibition of MDSCs may improve the prognosis of patients.
              Article 0 comments Cited 103 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Toshinori Murayama:
                ORCID: https://orcid.org/0000-0001-9635-357X
                Innovative Clinical Research CenterKanazawa University13-1 TakaramachiKanazawa, 9208641Japan81 762652049toshi@staff.kanazawa-u.ac.jp
                Journal
                Journal ID (nlm-ta): JMIR Res Protoc
                Journal ID (iso-abbrev): JMIR Res Protoc
                Journal ID (publisher-id): ResProt
                Title: JMIR Research Protocols
                Publisher: JMIR Publications (Toronto, Canada )
                ISSN (Electronic): 1929-0748
                Publication date Collection: February 2020
                Publication date (Electronic): 10 February 2020
                Volume: 9
                Issue: 2
                Electronic Location Identifier: e17082
                Affiliations
                [1 ] Innovative Clinical Research Center Kanazawa University Kanazawa Japan
                [2 ] Department of Gastroenterology Kanazawa University Hospital Kanazawa Japan
                Author notes
                Corresponding Author: Toshinori Murayama toshi@ 123456staff.kanazawa-u.ac.jp
                Author information
                https://orcid.org/0000-0001-6647-8240
                https://orcid.org/0000-0002-1052-0101
                https://orcid.org/0000-0002-2036-9599
                https://orcid.org/0000-0003-3053-4356
                https://orcid.org/0000-0001-9635-357X
                https://orcid.org/0000-0002-3137-8183
                Article
                Publisher ID: v9i2e17082
                DOI: 10.2196/17082
                PMC ID: 7055781
                PubMed ID: 32039814
                SO-VID: 5d25e3f9-fb2d-44d3-a787-1cb9807e5f06
                Copyright © ©Akihiro Nomura, Takeshi Terashima, Eishiro Mizukoshi, Masaaki Kitahara, Toshinori Murayama, Shuichi Kaneko. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 10.02.2020.
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                History
                Date received : 15 November 2019
                Date revision requested : 12 December 2019
                Date revision received : 20 December 2019
                Date accepted : 7 January 2020
                Categories
                Subject: Protocol
                Subject: Protocol

                Keywords: hepatocellular carcinoma,alpha-fetoprotein-derived peptides,safety trial
                Data availability:
                Keywords: hepatocellular carcinoma, alpha-fetoprotein-derived peptides, safety trial

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