Vol 12: Phase I clinical trial of multiple-peptide vaccination for patients with advanced biliary tract cancer.Report as inadecuate



 Vol 12: Phase I clinical trial of multiple-peptide vaccination for patients with advanced biliary tract cancer.


Vol 12: Phase I clinical trial of multiple-peptide vaccination for patients with advanced biliary tract cancer. - Download this document for free, or read online. Document in PDF available to download.

Download or read this book online for free in PDF: Vol 12: Phase I clinical trial of multiple-peptide vaccination for patients with advanced biliary tract cancer.
This article is from Journal of Translational Medicine, volume 12.AbstractBackground: The prognosis of patients with advanced biliary tract cancer BTC is extremely poor and only a few standard treatments are available for this condition. We performed a phase I trial to investigate the safety, immune response and anti-tumor effect of vaccination with three peptides derived from cancer-testis antigens. Methods: This study was conducted as a phase I trial. Nine patients with advanced BTC who had unresectable tumors and were refractory to standard chemotherapy were enrolled. Three HLA-A*2402 restricted epitope peptides-cell division cycle associated 1 CDCA1, cadherin 3 CDH3 and kinesin family member 20A KIF20A-were administered subcutaneously, and the adverse events and immune response were assessed. The clinical effects observed were the tumor response, progression-free survival PFS and overall survival OS. Results: The three-peptide vaccination was well-tolerated up to a dose of 3 mg per peptide 9 mg total. No grade 3 or 4 adverse events were observed after vaccination. Peptide-specific T cell immune responses were observed in all patients and stable disease was observed in 5 of 9 patients. The median PFS and OS were 3.4 and 9.7 months. The Grade 2 injection site reaction and continuous vaccination after PD judgment appeared to be prognostic of OS. Conclusions: Multiple-peptide vaccination was well tolerated and induced peptide-specific T-cell responses. Trial registration: This study was registered with the University Hospital Medical Information Network Clinical Trials Registry UMIN-CTR000003229.



Author: Aruga, Atsushi; Takeshita, Nobuhiro; Kotera, Yoshihito; Okuyama, Ryuji; Matsushita, Norimasa; Ohta, Takehiro; Takeda, Kazuyoshi; Yamamoto, Masakazu

Source: https://archive.org/







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