Postoperative adjuvant immunotherapy of tumor specific peptide vaccine for esophageal cancer patients with pathological lymph node metastasis who underwent preoperative therapy followed by surgery- single institute exploratory Phase II trial

Conditions

esophageal cancer

Takushi Yasuda, Kohei Nishiki, Yoko Hiraki, Hiroaki Kato, Mitsuru Iwama et al. (16 authors)

Diseases of the Esophagus2021-09-01

Phase II Adjuvant Cancer-specific Vaccine Therapy for Esophageal Cancer Patients Curatively Resected After Preoperative Therapy With Pathologically Positive Nodes; Possible Significance of Tumor Immune Microenvironment in its Clinical Effects

Takushi Yasuda, Kohei Nishiki, Yoko Hiraki, Hiroaki Kato, Mitsuru Iwama et al. (16 authors)

Annals of Surgery2020-08-2622 citations

10.1097/sla.0000000000003880

Cancer peptide vaccine to suppress postoperative recurrence in esophageal SCC patients with induction of antigen-specific CD8+ T cell.

Takushi Yasuda, Kohei Nishiki, Koji Yoshida, Osamu Shiraishi, Mitsuru Iwama et al. (11 authors)

Journal of Clinical Oncology2017-05-2010 citations

10.1200/jco.2017.35.15_suppl.e14635

Adjuvant cancer peptide vaccine for pathological node-positive esophageal SCC patients who underwent preoperative therapy followed by R0 resection.

Takushi Yasuda, Kohei Nishiki, Koji Yoshida, Osamu Shiraishi, Mitsuru Iwama et al. (12 authors)

Journal of Clinical Oncology2016-05-20

10.1200/jco.2016.34.15_suppl.3087

Interventions

Patients with HLA-A*2402 will undergo 2 set of weekly vaccination for 5 weeks followed by byweekly vaccinotion for 10 weeks. On each vaccination day, 1mg of the HLA-A*2402-restricted URLC10, CDCA1 and

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients with esophageal SCC who underwent currative (R0) resection after preoperative treatment and had pathological LN metastases 2)Laboratory values as follows Hemoglobin > 8.0g/dL 2000/mm3 < WBC < 15000mm3 Platelet count > 70000/mm3 Total bilirubin < 1.5mg/dL Asparate transaminase < 150U/L Alanine transaminase < 150U/L Serum creatinine < 3.0mg/dL PaO2 > 70mmHg 3)ECOG performance status 0-1 4)Age between 20 to 84 5)Male and female 6)Able and willing to give valid written informed consent

Exclusion criteria

Exclusion criteria: 1)Infectious disease (ex. patients with high fever of 38.5 degrees C or more, et cetra) 2)Severe heart disease or past history of the disease 3)Severe postoperative complications (ileus, interstitial pneumonia, uncontrolled DM, renal failure, cirrhosis, et cetra) 4)Severe mental disorder 5)Another active malignant disease 6)Brestfeeding and pregnancy (woman of child bearing potential) 7)Man with an intention to get with child 8)Autoimmune disease 9)Retention of pericardial fluid to cause heart failure or pericarditis 10)Decision of unsuitableness by principal investigator or physician-in-charge

Design outcomes

Primary

Measure	Time frame
Relapse free Survival	—

Secondary

Measure	Time frame
Esophageal cancer specific survival Overall survival Adverse event Feasibility immunological response Expression of tumor specific antigen Expression of HLA calss I Expression of CD(+ T cell and PDL1	—

Countries

Japan

Contacts

Public ContactTakushi Yasuda

Kindai University Faculty of Medicine Department of Surgery

takushi-yasuda6008@med.kindai.ac.jp072-366-0221

Outcome results

None listed