Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries.
Hyuna Sung, Jacques Ferlay, Rebecca L Siegel...
https://pubmed.ncbi.nlm.nih.gov/33538338Actively Recruiting
Age: 19Years +
All Genders
ID06767436
A Multi-center Cohort Study to Evaluate the Real-world Efficacy and Safety of Trastuzumab-deruxtecan in Advanced Gastric Cancer
Led by Yonsei University · Updated on 2025-01-09
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are collecting real-world data on patients with advanced gastric cancer who started treatment with trastuzumab-deruxtecan (Enhertu) from September 2022 onward. This observational study includes patients with metastatic, recurrent, or unresectable gastric or gastroesophageal adenocarcinoma that is HER2-positive. The study aims to evaluate the efficacy and safety of trastuzumab-deruxtecan by analyzing outcomes such as overall survival, progression-free survival, and tumor response rates. The study involves patients who have received trastuzumab-deruxtecan as a third-line or later treatment. Data collection includes patients currently undergoing treatment, those scheduled to receive treatment, and those who have progressed to subsequent chemotherapy after trastuzumab-deruxtecan. For patients no longer visiting due to hospice care or deceased, clinical data will be collected without consent until August 19, 2024. For others with newly added data after registration, data collection with consent continues until March 31, 2027. Participants will have their clinical data gathered from selected institutions, including treatment records and outcomes related to safety and efficacy. The primary outcome measured is progression-free survival at one year. Secondary outcomes include the number of participants with treatment-related adverse events and correlation analyses. The study is led by Yonsei University and will continue data collection until November 4, 2025, with extended follow-up for some patients through 2027.
CONDITIONS
Brief Title
A Multi-center Real-world Efficacy and Safety of Trastuzumab-deruxtecan in Advanced Gastric Cancer
Who Can Participate
Age: 19Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged 19 years or older.
- Patients with pathologically confirmed metastatic, recurrent, or unresectable gastric or gastroesophageal adenocarcinoma.
- Patients whose tumor tissue shows HER2 immunohistochemistry results of 3+ or 2+ with in-situ hybridization positivity.
- Patients who received trastuzumab-deruxtecan as third-line or later treatment.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to approximately 2 years and 7 months
Participants who received trastuzumab-deruxtecan as part of routine care are observed to collect clinical data on efficacy and safety.
Visit frequency as per routine clinical care
Trial Site Locations
Total: 1 location
1
minkyu Jung
Seoul, Seoul, South Korea, 03722
Actively Recruiting
Loading map...
Research Team
M
minkyu Jung
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Trastuzumab Deruxtecan in Previously Treated HER2-Positive Gastric Cancer.
Kohei Shitara, Yung-Jue Bang, Satoru Iwasa...
https://pubmed.ncbi.nlm.nih.gov/32469182