Adjuvant Alpha-Fetoprotein-Derived Peptide After Transarterial Chemoembolization in Patients With Hepatocellular Carcinoma: Protocol for a Safety Study
BackgroundHepatocellular 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 H...
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| Format: | Article |
| Language: | English |
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JMIR Publications
2020-02-01
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| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2020/2/e17082 |
| _version_ | 1818902294465347584 |
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| author | Nomura, Akihiro Terashima, Takeshi Mizukoshi, Eishiro Kitahara, Masaaki Murayama, Toshinori Kaneko, Shuichi |
| author_facet | Nomura, Akihiro Terashima, Takeshi Mizukoshi, Eishiro Kitahara, Masaaki Murayama, Toshinori Kaneko, Shuichi |
| author_sort | Nomura, Akihiro |
| collection | DOAJ |
| description | BackgroundHepatocellular 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.
ObjectiveThis study aims to evaluate the safety of alpha-fetoprotein (AFP)-derived peptides for patients with HCC post-TACE.
MethodsThis 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).
ResultsWe have recruited 14 patients with HCC as of December 2019. The final follow-up will be completed by March 2020.
ConclusionsIn 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 RegistrationJapan Registry of Clinical Trials jRCTs041180155; https://jrct.niph.go.jp/latest-detail/jRCTs041180155
International Registered Report Identifier (IRRID)DERR1-10.2196/17082 |
| first_indexed | 2024-12-19T20:33:22Z |
| format | Article |
| id | doaj.art-ed298395200b403c95368d69f17e9c20 |
| institution | Directory Open Access Journal |
| issn | 1929-0748 |
| language | English |
| last_indexed | 2024-12-19T20:33:22Z |
| publishDate | 2020-02-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | JMIR Research Protocols |
| spelling | doaj.art-ed298395200b403c95368d69f17e9c202022-12-21T20:06:38ZengJMIR PublicationsJMIR Research Protocols1929-07482020-02-0192e1708210.2196/17082Adjuvant Alpha-Fetoprotein-Derived Peptide After Transarterial Chemoembolization in Patients With Hepatocellular Carcinoma: Protocol for a Safety StudyNomura, AkihiroTerashima, TakeshiMizukoshi, EishiroKitahara, MasaakiMurayama, ToshinoriKaneko, ShuichiBackgroundHepatocellular 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. ObjectiveThis study aims to evaluate the safety of alpha-fetoprotein (AFP)-derived peptides for patients with HCC post-TACE. MethodsThis 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). ResultsWe have recruited 14 patients with HCC as of December 2019. The final follow-up will be completed by March 2020. ConclusionsIn 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 RegistrationJapan Registry of Clinical Trials jRCTs041180155; https://jrct.niph.go.jp/latest-detail/jRCTs041180155 International Registered Report Identifier (IRRID)DERR1-10.2196/17082https://www.researchprotocols.org/2020/2/e17082 |
| spellingShingle | Nomura, Akihiro Terashima, Takeshi Mizukoshi, Eishiro Kitahara, Masaaki Murayama, Toshinori Kaneko, Shuichi Adjuvant Alpha-Fetoprotein-Derived Peptide After Transarterial Chemoembolization in Patients With Hepatocellular Carcinoma: Protocol for a Safety Study JMIR Research Protocols |
| title | Adjuvant Alpha-Fetoprotein-Derived Peptide After Transarterial Chemoembolization in Patients With Hepatocellular Carcinoma: Protocol for a Safety Study |
| title_full | Adjuvant Alpha-Fetoprotein-Derived Peptide After Transarterial Chemoembolization in Patients With Hepatocellular Carcinoma: Protocol for a Safety Study |
| title_fullStr | Adjuvant Alpha-Fetoprotein-Derived Peptide After Transarterial Chemoembolization in Patients With Hepatocellular Carcinoma: Protocol for a Safety Study |
| title_full_unstemmed | Adjuvant Alpha-Fetoprotein-Derived Peptide After Transarterial Chemoembolization in Patients With Hepatocellular Carcinoma: Protocol for a Safety Study |
| title_short | Adjuvant Alpha-Fetoprotein-Derived Peptide After Transarterial Chemoembolization in Patients With Hepatocellular Carcinoma: Protocol for a Safety Study |
| title_sort | adjuvant alpha fetoprotein derived peptide after transarterial chemoembolization in patients with hepatocellular carcinoma protocol for a safety study |
| url | https://www.researchprotocols.org/2020/2/e17082 |
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