Tokyo, Dec. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059965) titled 'Multicenter Retrospective Observational Study on Treatment Outcomes of Chemotherapy Combined with Zolbetuximab for Unresectable Advanced or Recurrent Gastric Cancer' on Dec. 4.
Study Type:
Observational
Primary Sponsor:
Institute - Hokkaido Gastrointestinal Cancer Chemotherapy Study Group
Condition:
Condition - Unresectable advanced or recurrent gastric cancer
Classification by malignancy - Malignancy
Genomic information - YES
Objective:
Narrative objectives1 - To clarify the adverse events and treatment outcomes of solutaximab combination therapy for unresectable advanced or recurrent gastric or gastroesophageal junction cancer that is HER2-negative and CLDN18.2-positive in actual clinical practice in Japan.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key 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
Key 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
Target Size - 60
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 11 Month 21 Day
Date of IRB - 2025 Year 11 Month 21 Day
Anticipated trial start date - 2025 Year 11 Month 21 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068587
Disclaimer: Curated by HT Syndication.
