Real-world Effectiveness and Safety of Trastuzumab Deruxtecan in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma in China
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Trastuzumab deruxtecan (T-DXd).
- Who it may be relevant to
- Registry conditions: HER2-positive Gastric Cancer, HER2-positive Gastroesophageal Junction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
- Drug Trastuzumab deruxtecan (T-DXd)
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.
Primary outcome measures
- Real-world Time to Treatment Failure (rwTTF) [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]
Secondary outcome measures (2)
- Number of Participants Reporting Treatment Related Adverse Events (TRAE) and Physician-reported Adverse Event of Special Interest (AESI), Regardless of Grade [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) [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]
Eligibility criteria
Participants must meet all the following inclusion criteria to be eligible for the study:
- 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 Criteria：
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 36 centers
- China-Japan Friendship Hospital — Beijing
- Peking Union Medical College Hospital — Beijing
- Peking University First Hospital — Beijing
- Beijing Cancer Hospital — Beijing
- Beijing GoBroad Hospital — Beijing
- The First Hospital of Jilin University — Changchun
- Changzhi People's Hospital — Changzhi
- Fujian Cancer Hospital — Fuzhou
- … and 28 more centers
Identifiers
NCT: NCT06846996 · DS8201-0076-NIS-MA