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.
The primary objective of this study is to evaluate the effectiveness of T-DXd in real-world setting (real-word time to treatment failure). The secondary objectives of this study are to assess the safety profile of T-DXd (treatment related adverse events \[TRAE\] regardless of grade, and physician reported adverse events of special interest \[AESI\] regardless of grade, etc.) and to evaluate effectiveness of T-DXd (real-world time to next treatment). This is an non-interventional, observational study. No drug will be provided or administered as part of this protocol; however, participants on T-DXd will be enrolled in this study.
Study Type
OBSERVATIONAL
Enrollment
260
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.
China-Japan Friendship Hospital
Beijing, China
RECRUITINGPeking Union Medical College Hospital
Beijing, China
NOT_YET_RECRUITINGPeking University First Hospital
Beijing, China
RECRUITINGBeijing Cancer Hospital
Beijing, China
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.
Time frame: T-DXd treatment initiation date (index date) to date of treatment discontinuation due to disease progression, physician decision, adverse events or death, whichever occurs first, up to approximately 2 years
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.
Time frame: T-DXd treatment initiation date (index date) until end of study, or death, or withdrawal of consent, or loss to follow-up (LTFU), or study closure, whichever occurs first, up to approximately 2 years
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.
Time frame: T-DXd treatment initiation date (index date) to the date of receiving next line anti-cancer treatment or death, whichever occurs first, up to approximately 2 years
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Beijing GoBroad Hospital
Beijing, China
RECRUITINGThe First Hospital of Jilin University
Changchun, China
NOT_YET_RECRUITINGChangzhi People's Hospital
Changzhi, China
RECRUITINGFujian Cancer Hospital
Fuzhou, China
RECRUITINGGuangdong Provincial People's Hospital
Guangzhou, China
RECRUITINGThe First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
RECRUITING...and 26 more locations