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Multicenter Retrospective Observational Study on Treatment Outcomes of Chemotherapy Combined with Zolbetuximab for Unresectable Advanced or Recurrent Gastric Cancer

Multicenter Retrospective Observational Study on Treatment Outcomes of Chemotherapy Combined with Zolbetuximab for Unresectable Advanced or Recurrent Gastric Cancer - HGCSG2501

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000059965
Enrollment
60
Registered
2025-12-04
Start date
2025-11-21
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable advanced or recurrent gastric cancer

Interventions

None listed

Sponsors

Hokkaido Gastrointestinal Cancer Chemotherapy Study Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients pathologically diagnosed with unresectable advanced or recurrent gastric adenocarcinoma or gastroesophageal junction adenocarcinoma 2) Patients confirmed to be HER2-negative and CLDN18.2-positive by pathology 3) Patients who received zolbeximab in combination with fluoropyrimidine antineoplastic agents (5-FU, S-1, capecitabine) and oxaliplatin (cases where administration of other agents was not possible after zolbeximab due to adverse events, etc., despite planned combination therapy are acceptable). Treatment line is not restricted. 4) Patients aged 20 years or older at diagnosis 5) Patients who did not refuse participation in this study

Exclusion criteria

Exclusion criteria: 1) Patients who received combination therapy with fluoropyrimidine antineoplastic agents (5-FU, S-1, capecitabine) or antineoplastic agents other than oxaliplatin and solubeximab, regardless of the route of administration 2) Other patients deemed unsuitable for inclusion in the study by the principal investigator

Design outcomes

Primary

MeasureTime frame
Safety

Secondary

MeasureTime frame
OS, PFS, TTF, best overall response, treatment response predictors, prognostic predictors

Countries

Japan

Contacts

Public ContactKazuaki Harada

Hokkaido University Hospital Tumor Center

haraharaccho0605@yahoo.co.jp011-716-1161

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026