Collecting real-world data on trastuzumab-deruxtecan for advanced gastric cancer
A Multi-center Cohort Study to Evaluate the Real-world Efficacy and Safety of Trastuzumab-deruxtecan in Advanced Gastric Cancer
Yonsei University · NCT06767436
This study is collecting real-world information from patients with advanced gastric cancer who are being treated with trastuzumab-deruxtecan to see how well the treatment works and how it affects their lives.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Yonsei University (other) |
| Drugs / interventions | Trastuzumab, chemotherapy |
| Locations | 1 site (Seoul, Seoul) |
| Trial ID | NCT06767436 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather real-world data on patients with advanced gastric cancer who have started treatment with trastuzumab-deruxtecan (Enhertu) since September 2022. It will collect clinical data from patients currently undergoing treatment, those who have experienced disease progression, and those who have passed away or are in hospice care. The study will evaluate efficacy through metrics such as overall survival, progression-free survival, and tumor response rate, with data collection continuing until March 2027 for consenting patients.
Who should consider this trial
Good fit: Ideal candidates include patients aged 19 years or older with HER2-positive metastatic, recurrent, or unresectable gastric/gastroesophageal adenocarcinoma who have received trastuzumab-deruxtecan as a third-line or later treatment.
Not a fit: Patients with HER2-negative gastric cancer or those who have not consented to participate will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness and safety of trastuzumab-deruxtecan for patients with advanced gastric cancer.
How similar studies have performed: Other studies have shown success with real-world data collection for cancer treatments, indicating that this approach is promising and not entirely novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Seoul, Seoul
- minkyu Jung — Seoul, Seoul, South Korea (RECRUITING)
Study contacts
- Principal investigator: minkyu Jung — Yonsei Cencer center
- Study coordinator: minkyu Jung
- Email: minkjung@yuhs.ac
- Phone: 0222278406
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Advanced Gastric Cancer, Trastuzumab-deruxtecan