ADVANCED/GASTRIC CANCER
Conditions
Interventions
None listed
Sponsors
Bristol-Myers Squibb K.K. Ono Pharmaceutical CO.LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To participate in this study, the following criteria MUST be met at the time of informed consent: 1.Patients aged over 20 years. 2.Patients with histologically confirmed advanced or recurrent gastric cancer. 3.Patients who have initiated or are confirmed to receive nivolumab plus chemotherapy as the first-line therapy between the date of approval of nivolumab plus chemotherapy and December 31, 2022. For combination chemotherapy, SOX, CapeOX, or FOLFOX is acceptable. Patients who have signed a written informed consent form of their own free will after they have been given an adequate explanation and a full understanding of this study before enrolling in this study. If it is difficult to obtain consent from the patient, the following points a) through c) are acceptable: a) Patients who have difficulty writing may be registered in this study by a person equivalent to a legally acceptable representative writing on their behalf, with the patient's oral consent. b) Patients who have difficulty obtaining consent may be registered in this study if written consent is obtained from the legally acceptable representative after explanation to the legally acceptable representative. c)If it is difficult to obtain informed consent from the patient or legally acceptable representative for various reasons other than a) and b), registration is allowed by opt-out.
Exclusion criteria
Exclusion criteria: To participate in this study, the following criteria MUST NOT be met at the time of informed consent: 1.Patients who have been treated with antineoplastic agents as first-line treatment for advanced or recurrent gastric cancer prior to the initiation of nivolumab plus chemotherapy (patients who have received prior perioperative chemotherapy and patients who have received prior bisphosphonates for osseous metastases may be enrolled). 2.Patients who have been confirmed to be positive for HER2. 3.Patients who have been diagnosed with gastric cancer and have previously received investigational drugs with anti-tumor effects for gastric cancer. 4.Patients who were initiated with nivolumab plus chemotherapy as the first-line treatment for advanced or recurrent gastric cancer at a site other than the study site and were later hospitalized at the study site. 5.Other patients judged by the investigators to be inappropriate for enrollment in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness -Progression-free survival (PFS) -Objective response rate (ORR) Safety -Incidence of all immune-related adverse events (irAE) according to CTCAE v5.0 -Incidence of treatment-related adverse events (TRAE) that have led to treatment discontinuation | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness -Overall survival (OS) -Duration of treatment (DOT) -Duration of response (DOR) -DOT of second-line treatment -PFS, ORR, and DOT of nivolumab treatment in third or later line treatment -OS, PFS, ORR, and DOT by patient characteristics Actual treatment status -Time to next treatment (TNT) -Rate of patients who have received subsequent therapy -Treatment status Safety -Safety by patient characteristics | — |
Countries
Japan
Contacts
Public ContactMayu Kakiuchi
Mebix, Inc Research Promotion Headquarters
Outcome results
None listed