Real-world Effectiveness and Safety of Trastuzumab Deruxtecan in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma in China
NCT06846996 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 260
Last updated 2025-07-08
Summary
Trastuzumab deruxtecan's (T-DXd's) efficacy and safety has been confirmed in traditional clinical trials, there is a lack of real-world evidence, especially among Chinese patients. The objective of this study is to evaluate real-world effectiveness and safety profile of T-DXd by collecting real-world data treating in patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
Conditions
- HER2-positive Gastric Cancer
- HER2-positive Gastroesophageal Junction
Interventions
- DRUG
-
Trastuzumab deruxtecan (T-DXd)
This is an non-interventional, observational study. No drug will be provided or administered as part of this protocol; however, participants on T-DXd (starting dose 6.4 mg/kg IV Q3W) will be enrolled in this study as part of clinical routine or the clinical judgement of physician.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Project Manager · Daiichi Sankyo Co., Ltd.
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-27
- Primary Completion
- 2027-07-31
- Completion
- 2027-07-31
- FDA Drug
- Yes
Countries
- China
Study Locations
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