NCT06767436

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

A Multi-center Cohort Study to Evaluate the Real-world Efficacy and Safety of Trastuzumab-deruxtecan in Advanced Gastric Cancer

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: —

Summary

* Institutions will be selected * This study aims to collect real-world data, targeting patients who started treatment with Enhertu from September 2022, for clinical data collection * Among patients treated with Enhertu, those who have passed away or are no longer visiting due to hospice care will have their clinical data collected without consent until August 19, 2024 * For patients who are scheduled to receive Enhertu treatment, are currently undergoing treatment, or have previously undergone treatment but experienced disease progression and are now receiving subsequent chemotherapy (i.e., patients with newly added data after registration) * Efficacy evaluation

Detailed description

* Institutions will be selected through the Gastric Cancer Subcommittee of the Korean Cancer Study Group. * This study aims to collect real-world data, targeting patients who started treatment with trastuzumab-deruxtecan from September 2022, for clinical data collection. * Among patients treated with trastuzumab-deruxtecan, those who have passed away or are no longer visiting due to hospice care will have their clinical data collected without consent until August 19, 2024. * For patients who are scheduled to receive Enhertu treatment, are currently undergoing treatment, or have previously undergone treatment but experienced disease progression and are now receiving subsequent chemotherapy (i.e., patients with newly added data after registration), data will be collected with consent until March 31, 2027. * Efficacy evaluation will include overall survival (OS), progression-free survival (PFS), and tumor response rate (TRR)

Conditions

• Advanced Gastric Cancer

Timeline

• Start date: 2024-11-05
• Primary completion: 2025-11-04
• Completion: 2025-11-04
• First posted: 2025-01-09
• Last updated: 2025-01-09

Locations

1 site across 1 country: South Korea