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.
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.
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.
Eligible participants for this study include participants with HER2-positive local advanced or metastatic GC/GEJA.
Cohort
Prospective
Trastuzumab deruxtecan (T-DXd)
DrugThis 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.
Real-world Time to Treatment Failure (rwTTF)
rwTTF is defined as time from T-DXd treatment initiation date to the earliest date of treatment discontinuation due to disease progression, physician decision, adverse events or death.
Number of Participants Reporting Treatment Related Adverse Events (TRAE) and Physician-reported Adverse Event of Special Interest (AESI), Regardless of Grade
A TRAE is defined as a harmful reaction, resulting from the normal usage and dosage to a medicinal product, which is unrelated to the purpose of medication. Physician-reported AESIs are defined as interstitial lung disease/pneumonitis and left ventricular ejection fraction decrease.
Real-world Time to Next Treatment (rwTTNT)
rwTTNT is defined as time from T-DXd treatment initiation date to the earliest date of receiving next line anti-cancer treatment, or death.
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