Gastric Cancer Gastric Cancer
Conditions
Interventions
SOX+Zolvetuximab combination group:
(1) Zolvetuximab: 600mg/m2 on Day1 (800mg/m2 for the first course).
(2) Oxaliplatin: 130 mg/m2 on Day 1.
(3) S-1: 40mg/m2 twice daily from Day 1 to Day 14.
Repeat t
Sponsors
Fujii Masashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with histologically confirmed gastric cancer (either one of the general histological types or lymphocyte-infiltrated gastric cancer) (including esophagogastric junction cancer) (2) Patients with an ECOG Performance Status (PS) of 0 to 1. (3) Patients who are at least 18 years of age at the time of consent (4) Patients with confirmed HER2 negative (5) Patients with confirmed CLDN18.2 positive (6) Patients with measurable and/or unmeasurable lesions based on RECIST ver. 1.1 on imaging evaluation within 28 days prior to enrollment. (7) Patients who are able to take oral intake. (8) Patients with no history of chemotherapy or radiotherapy for unresectable advanced or recurrent gastric cancer (9) Patients with preserved major organ function (10) Patients who have been fully informed of the details of this study and have given their written consent.
Exclusion criteria
Exclusion criteria: (1) Patients with a history of prior drug therapy targeting CLDN18.2 (2) Patients with a history of hypersensitivity to tegafur/gimerasil/oterasil potassium combination (S-1), capecitabine, fluorouracil, oxaliplatin, or other platinum drugs (3) Patients with relapse within 180 days after completion of preoperative platinum-containing adjuvant chemotherapy or adjuvant chemoradiotherapy. (4) Patients with recurrence during or within 180 days after completion of postoperative adjuvant chemotherapy including fluoropyrimidines. (5) Patients known to have MSI-H or dMMR. (6) Patients with a history of surgical treatment within 14 days prior to enrollment (7) Patients who received red blood cell or platelet transfusion within 14 days prior to registration (8) Patients with synchronous multiple cancers or iatrogenic multiple cancers with a disease-free period of 5 years or less (however, lesions equivalent to intraepithelial or intramucosal cancers that are considered curable by local treatment are not included in active multiple cancers) (9) Patients with metastasis to the symptomatic central nervous system (brain, spinal cord, meninges) (10) Patients with Grade 2 or higher nausea, vomiting, or peripheral sensory neuropathy (11) Patients with infections requiring systemic treatment (12) Patients with diabetes mellitus that is poorly controlled by continuous use of insulin (13) Patients with psychiatric disorders or psychiatric symptoms that would make participation in this study difficult. (14) Patients with suspected dementia or cognitive dysfunction who score less than 2 points on the Mini-Cog cognitive function test. (15) Pregnant women, nursing mothers who wish to continue breastfeeding, and patients who do not use contraception (16) Other cases that the principal investigator or sub-investigator determines to be inappropriate for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-month Progression-free Survival Rate by investigators review (SOX+Zolvetuximab combination group) | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) by investigator's review, PFS by central review, Overall Survival, Objective Response Rate (Investigator's review/ Central review: Only for patients with measurable disease), Disease Control Rate (Investigator's review/ Central review: Only for patients with measurable disease), Duration of Response, Time to response, Adverse Events, Adverse events, Percentage change in adverse events during the study period | — |
Contacts
Public ContactHisato Kawakami
Tohoku University Hospital
Outcome results
None listed