Unresectable advanced or recurrent gastric cancer
Conditions
Interventions
None listed
Sponsors
Aichi Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Unresectable or recurrent gastric cancer with histologically confirmed gastric adenocarcinoma. Esophagogastric junction carcinoma with the center of the tumor within 2 cm from the esophagogastric junction is also acceptable. 2) ECOG performance status (PS): 0-2 3) Age: 18 years or older 4) Confirmed disease progression after achieved CR/PR or SD lasting at least 6 months to prior therapy including anti-PD-1/PD-L1 antibody therapy.(see a.-e. below) a.Any type of anti-PD-1/PD-L1 antibody. b. Any treatment regimen or line except neoadjuvant or adjuvant therapy. Patients who were treated for the purpose of conversion surgery and who have evaluable lesion can be enrolled. c. Cases in which anti-PD-1/PD-L1 antibody were concomitantly administered during the course of the same treatment regimen or line, or were discontinued during the course of the regimen for reasons other than intolerance can be enrolled. d. Patients treated with anti-PD-1/PD-L1 antibody as monotherapy can be enrolled. e. Patients who were treated with following therapy before confirming disease progression are not eligible for registration. 5) Patients who were treated at least one regimen of any anti-cancer therapy after the prior therapy including anti-PD-1/PD-L1 antibodies. 6) Patients who are treated ICI re-administration for the first time. 7) Patients with measurable lesions by RECIST (ver. 1.1) 8) Patients who have been fully informed about the study and have given their written consent.
Exclusion criteria
Exclusion criteria: 1) Patients with multiple cancers requiring systemic therapy excluding hormonal therapy. 2) Patients who are inappropriate for re-administration of nivolumab by the treating physician due to serious irAEs in previous therapy including anti-PD-1/PD-L1 antibodies. Patients with endocrine abnormalities and who can be re-administered nivolmab with hormone replacement can be enrolled. 3) Patients receiving continuous systemic administration of steroids or immunosuppressive agents with a prednisone equivalent of more than 10 mg/day (or equivalent dose) 4) Patients who are inappropriate for enrollment in this study by the treating physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Overall Survival (OS) after re-administration of nivolumab 2)Disease control rate (DCR) of nivolumab re-administration 3)Progression Free Survival (PFS) after nivolumab re-administration 4) Time to Treatment Failure (TTF) after nivolumab re-administration 5) RR, DCR, OS, PFS, and TTF by the following subgroups a. Combined positive score (CPS) score (CPS<1, 1<=CPS<5, 5<=CPS) b. Best response to prior therapy including anti-PD-1/PD-L1 antibody c. History of treatment with FTD/TPI or irinotecan d. HER2 status 6) irAE in nivolumab re-administration (CTCAE v5.0) 7) Other efficacy analysis by patient background | — |
Countries
Japan
Contacts
Public ContactHiroyuki Kodama
Aichi Cancer Center Department of Clinical Oncology
Outcome results
None listed