A Multi-center Real-world Efficacy and Safety of Trastuzumab-deruxtecan in Advanced Gastric Cancer
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
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Advanced Gastric Cancer. Basic parameters: from 19 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
- South Korea
- 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
A Multi-center Cohort Study to Evaluate the Real-world Efficacy and Safety of Trastuzumab-deruxtecan in Advanced Gastric Cancer
Overview
* Institutions will be selected * This study aims to collect real-world data, targeting patients who started treatment with Enhertu from September 2022, for clinical data collection * Among patients treated with Enhertu, those who have passed away or are no longer visiting due to hospice care will have their clinical data collected without consent until August 19, 2024 * For patients who are scheduled to receive Enhertu treatment, are currently undergoing treatment, or have previously undergone treatment but experienced disease progression and are now receiving subsequent chemotherapy (i.e., patients with newly added data after registration) * Efficacy evaluation
Detailed description
* Institutions will be selected through the Gastric Cancer Subcommittee of the Korean Cancer Study Group. * This study aims to collect real-world data, targeting patients who started treatment with trastuzumab-deruxtecan from September 2022, for clinical data collection. * Among patients treated with trastuzumab-deruxtecan, those who have passed away or are no longer visiting due to hospice care will have their clinical data collected without consent until August 19, 2024. * For patients who are scheduled to receive Enhertu treatment, are currently undergoing treatment, or have previously undergone treatment but experienced disease progression and are now receiving subsequent chemotherapy (i.e., patients with newly added data after registration), data will be collected with consent until March 31, 2027. * Efficacy evaluation will include overall survival (OS), progression-free survival (PFS), and tumor response rate (TRR)
Primary outcome measures
- Progression-free Survival [Time frame: 1 year]
Secondary outcome measures (2)
- Number of participants with treatment-related adverse events [Time frame: 1 year]
- analyze the correlation [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Patients aged 19 years or older.
- Patients with pathologically confirmed metastatic, recurrent, or unresectable gastric/gastroesophageal adenocarcinoma.
- Patients whose tumor tissue shows HER2 immunohistochemistry (IHC) results of 3+ or 2+ with in-situ hybridization (ISH) positivity.
- Patients who received Trastuzumab Deruxtecan as third-line or later treatment.
Exclusion criteria
- Patients with HER2-negative gastric cancer.
- Patients who did not provide consent to participate in the study.
- Patients who received Trastuzumab Deruxtecan as first-line or second-line treatment as part of a clinical trial.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- minkyu Jung — Seoul
Publications
- Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338
- Shitara K, Bang YJ, Iwasa S, Sugimoto N, Ryu MH, Sakai D, Chung HC, Kawakami H, Yabusaki H, Lee J, Saito K, Kawaguchi Y, Kamio T, Kojima A, Sugihara M, Yamaguchi K; DESTINY-Gastric01 Investigators. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Gastric Cancer. N Engl J Med. 2020 Jun 18;382(25):2419-2430. doi: 10.1056/NEJMoa2004413. Epub 2020 May 29. PMID 32469182
Identifiers
NCT: NCT06767436 · 4-2024-1144