Tokyo, Dec. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059987) titled 'A Prospective Observational Study on the Dynamics of Claudin18.2, PD-L1, and HER2 Expression Following First-Line Treatment in Patients with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.' on Dec. 5.

Study Type: Observational

Primary Sponsor: Institute - St. Marianna University School of Medicine

Condition: Condition - To investigate the potential usefulness of zolbetuximab, primarily as a second-line or later treatment, by evaluating changes in key biomarkers, including Claudin 18.2 (CLDN18.2), before and after first-line treatment for unresectable gastric cancer and gastroesophageal junction cancer. Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To investigate the potential usefulness of zolbetuximab, primarily as a second-line or later treatment, by evaluating changes in key biomarkers, including Claudin 18.2 (CLDN18.2), before and after first-line treatment for unresectable gastric cancer and gastroesophageal junction cancer. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - (1)Unresectable gastric cancer or gastroesophageal junction cancer (2)Histologically confirmed adenocarcinoma (3)CLDN18.2, PD-L1 CPS (22C3), and HER2 status are known before the start of first-line treatment (4)There is a Primary tumor (5)Patients currently undergoing any of the following first-line treatments, or whose first-line treatments have been discontinued due to reactivity, intolerance, or patient preference: A.Zolbetuximab-containing chemotherapy* for HER2-negative and CLDN18.2-positive patients B.Anti-PD-1 antibody-containing chemotherapy* for HER2-negative and CLDN18.2-negative patients C.Trastuzumab-containing chemotherapy* for HER2-positive patients (including chemotherapy + trastuzumab + pembrolizumab) *Chemotherapy: Fluoropyrimidine preparations + platinum (6)Patients scheduled for upper gastrointestinal endoscopy and biopsy for the purpose of primary tumor evaluation, etc., upon discontinuation of first-line treatment Key exclusion criteria - (1)Cases in which the treatment period (start date to stop date) of first-line treatment is less than 6 weeks (2)Cases in which second-line treatment has already begun (3)Cases in which the subject did not consent to the use of his/her specimen for research purposes. (4)Cases in which the principal investigator determines that participation in this study is inappropriate. Target Size - 90

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 11 Month 17 Day Date of IRB - 2025 Year 11 Month 17 Day Anticipated trial start date - 2025 Year 12 Month 05 Day Last follow-up date - 2027 Year 11 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067981

Disclaimer: Curated by HT Syndication.