Real-world Effectiveness and Safety of Trastuzumab Deruxtecan in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma in China
Real-world Effectiveness and Safety of Trastuzumab Deruxtecan in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma in China: A Nation-wide, Multi-center, Prospective, Non-interventional Study
Daiichi Sankyo
260 participants
Feb 27, 2025
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- Participants with pathologically diagnosed locally advanced unresectable or metastatic gastric cancer/gastroesophageal junction adenocarcinoma (GC/GEJA).
- ≥18 years of age at the time of starting the first dose of T-DXd and signing informed consent form (ICF), capable of providing informed consent.
- HER2-positive status (IHC 3+ or IHC 2+/ISH +).
- Received prior anti-cancer treatment regimens according to National Medical Products Administration indication or clinical judgement of physician.
- Decision to newly initiate T-DXd before study ICF signing. If the participants have started the first dose of T-DXd no longer than 21 days before enrollment, they could be enrolled if the signed and dated ICF could be obtained.
Exclusion Criteria5
- Participants who meet any of the following criteria will be excluded from the study:
- Pregnancy or breastfeeding.
- Participants who at the time of data collection of the study are participating in or have participated in an interventional study that remains blinded.
- Known hypersensitivity to either the drug substances or inactive ingredients in the drug product.
- Judged by the investigator to be unfit to participate in the study.
Interventions
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.
Locations(36)
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NCT06846996