Real-World Study of Trastuzumab-Deruxtecan Treatment in Adults with Advanced Gastric Cancer Evaluating Effectiveness and Safety Across Multiple Centers

What this Trial Is About

Researchers are collecting real-world data on patients with advanced gastric cancer who started treatment with trastuzumab-deruxtecan Enhertu from September 2022 onward. This observational study includes patients with metastatic, recurrent, or unresectable gastric or gastroesophageal adenocarcinoma that is HER2-positive. The study aims to evaluate the efficacy and safety of trastuzumab-deruxtecan by analyzing outcomes such as overall survival, progression-free survival, and tumor response rates. The study involves patients who have received trastuzumab-deruxtecan as a third-line or later treatment. Data collection includes patients currently undergoing treatment, those scheduled to receive treatment, and those who have progressed to subsequent chemotherapy after trastuzumab-deruxtecan. For patients no longer visiting due to hospice care or deceased, clinical data will be collected without consent until August 19, 2024. For others with newly added data after registration, data collection with consent continues until March 31, 2027. Participants will have their clinical data gathered from selected institutions, including treatment records and outcomes related to safety and efficacy. The primary outcome measured is progression-free survival at one year. Secondary outcomes include the number of participants with treatment-related adverse events and correlation analyses. The study is led by Yonsei University and will continue data collection until November 4, 2025, with extended follow-up for some patients through 2027.

A Multi-center Real-world Efficacy and Safety of Trastuzumab-deruxtecan in Advanced Gastric Cancer