HER2-positive Gastric Cancer, HER2-positive Gastroesophageal Junction
Conditions
Keywords
HER2-positive gastric cancer, HER2-positive gastroesophageal junction
Brief 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.
Detailed description
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.
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.
Sponsors
Daiichi Sankyo
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants must meet all the following inclusion criteria to be eligible for the study: 1. Participants with pathologically diagnosed locally advanced unresectable or metastatic gastric cancer/gastroesophageal junction adenocarcinoma (GC/GEJA). 2. ≥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. 3. HER2-positive status (IHC 3+ or IHC 2+/ISH +). 4. Received prior anti-cancer treatment regimens according to National Medical Products Administration indication or clinical judgement of physician. 5. 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 criteria
： Participants who meet any of the following criteria will be excluded from the study: 1. Pregnancy or breastfeeding. 2. Participants who at the time of data collection of the study are participating in or have participated in an interventional study that remains blinded. 3. Known hypersensitivity to either the drug substances or inactive ingredients in the drug product. 4. Judged by the investigator to be unfit to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Real-world Time to Treatment Failure (rwTTF) | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Treatment Related Adverse Events (TRAE) and Physician-reported Adverse Event of Special Interest (AESI), Regardless of Grade | 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 | 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) | 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 | rwTTNT is defined as time from T-DXd treatment initiation date to the earliest date of receiving next line anti-cancer treatment, or death. |
Countries
China
Contacts
Primary ContactContact for Clinical Trial Information
Outcome results
None listed