Gastric cancer
Conditions
Interventions
None listed
Sponsors
Hokkaido Gastrointestinal Cancer Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Prospective cohort: Confirmed by pathological examination to have primary adenocarcinoma of the stomach or gastroesophageal junction. Diagnosed with unresectable or advanced recurrent gastric cancer. Scheduled to receive triple therapy of nivolumab, S1 or capecitabine or fluorouracil, and oxaliplatin between the date of implementation approval and June 30, 2026. Patients for which no prior treatment for unresectable advanced or recurrent gastric cancer has been performed. However, cases that underwent perioperative chemotherapy may be enrolled if recurrence is confirmed 6 months or more after the end of perioperative chemotherapy. Stool or saliva can be collected. Retrospective cohort: Patients who underwent nivolumab combination chemotherapy after November 2021, and who have already started nivolumab combination chemotherapy at the time of enrollment. Patients who have been treated with a triple combination of nivolumab, S1 or capecitabine or fluorouracil, and oxaliplatin, but have discontinued one or two drugs due to adverse events, etc. are also eligible. Both ongoing and completed cases can be enrolled. Patients who have been treated with systemic chemotherapy with fluoropyrimidine drugs and oxaliplatin first and then with nivolumab from the second course are also eligible. Diagnosed with unresectable or advanced recurrent gastric cancer. ECOG PS 0 to 2 Patients have not undergone prior treatment for unresectable advanced or recurrent gastric cancer before nivolumab combination chemotherapy. However, patients who have undergone perioperative chemotherapy can be enrolled if recurrence is observed 6 months or more after the end of perioperative chemotherapy. The subject is given the opportunity to refuse study participation through the publication of an optout notice, etc., and does not express an intention to refuse.
Exclusion criteria
Exclusion criteria: Prospective cohort: HER2 positive cases Active multiple cancers. Fluid retention requiring drainage within 2 weeks prior to enrollment. Pulmonary fibrosis or interstitial pneumonia. Severe complications. Active infections. Active viral hepatitis. Poorly controlled diabetes. Clinically significant psychiatric or central nervous system disorders. Severe electrocardiogram abnormalities or clinically significant cardiac disease. Clinically suspected brain or cerebrospinal membrane metastases. Pregnant or lactating women, or men or women who do not use appropriate contraception. Nivolumab administration is contraindicated. Require continuous oral administration of steroids at a dose of 10mg per day or more in prednisolone equivalent. The attending physician judged to be inappropriate for participation in this study. Retrospective cohort: HER2 positive cases Patients had undergone two or more courses of systemic chemotherapy with fluoropyrimidine drugs and oxaliplatin for unresectable advanced or recurrent gastric cancer. Active secondary cancers. Body cavity fluid collection requiring drainage within 2 weeks. Pulmonary fibrosis or interstitial pneumonia. Serious complications. Active infections. Active viral hepatitis. Poorly controlled diabetes mellitus. Clinically significant psychiatric disorders or central nervous system disorders. Severe electrocardiogram abnormalities or clinically significant cardiac diseases. Clinically suspected brain metastasis or cerebrospinal membrane metastasis. Require continuous oral administration of steroids at a dose of 10 mg per day or more in prednisolone equivalent. The attending physician judges to be inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Countries
Japan
Contacts
Public ContactKazuaki Harada
Hokkaido university hospital Divison of Cancer Center
Outcome results
None listed