Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059075) titled 'Randomized Phase II trial Evaluating the Efficacy of ZolbEtuximab in the second-line for CLaudin18.2 Positive AdvanceD GAstric/EGJ Cancer Patients Previously Treated with Zolbetuximab and Platinum-Based Chemotherapy (ZELDA trial):Translational Biomarker Research (ZELDA-TR trial)' on Oct. 1.
Study Type:
Observational
Primary Sponsor:
Institute - Kyushu Studygroup of Clinical Cancer
Condition:
Condition - gastric cancer and esophagogastric junction (EGJ) cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - This translational research will perform exploratory and confirmatory analyses in patients enrolled in the ZELDA trial to investigate factors potentially associated with the efficacy and adverse events of chemotherapy involving zolbetuximab.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Subjects who have consented to the ZELDA study and who have provided their written consent for the study after receiving sufficient explanation regarding the content of this study.
Key exclusion criteria - (1) Subjects whose participation in this study is judged inappropriate by the investigator.
(2) Subjects who did not consent to use their samples in the study.
Target Size - 170
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 02 Day
Anticipated trial start date - 2025 Year 10 Month 01 Day
Last follow-up date - 2029 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067565
Disclaimer: Curated by HT Syndication.
