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.
Beijing Chaoyang Hospital, Capital Medical University
Beijing, China
RECRUITINGChinese Academy of Medical Sciences Cancer Hospital
Beijing, China
RECRUITINGChina-Japan Friendship Hospital
Beijing, China
RECRUITINGBeijing Friendship Hospital,Capital Medical University
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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Peking Union Medical College Hospital
Beijing, China
WITHDRAWNPeking University First Hospital
Beijing, China
RECRUITINGBeijing Cancer Hospital
Beijing, China
RECRUITINGBeijing GoBroad Hospital
Beijing, China
RECRUITINGThe First Hospital of Jilin University
Changchun, China
NOT_YET_RECRUITINGChangzhi People's Hospital
Changzhi, China
RECRUITING...and 30 more locations