Advanced Gastric Cancer
Conditions
Keywords
Trastuzumab-deruxtecan
Brief summary
* 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)
Interventions
None listed
Sponsors
Yonsei University
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | 1 year | To present real-world clinical outcomes of trastuzumab-deruxtecan as third-line or later treatment in HER2-positive gastric cancer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events | 1 year | Number of participants with treatment-related adverse events as assessed by CTCAE V5.0 |
| analyze the correlation | 1 year | To analyze the correlation between HER2 immunohistochemistry (IHC) results and the efficacy of trastuzumab-deruxtecan. |
Countries
South Korea
Contacts
Primary Contactminkyu Jung
Outcome results
None listed