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 Study Evaluating 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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to collect real-world data on patients with advanced gastric cancer who started treatment with trastuzumab-deruxtecan (also called Enhertu) from September 2022. The study focuses on patients with metastatic, recurrent, or unresectable gastric or gastroesophageal adenocarcinoma whose tumors show positive HER2 test results. It evaluates the effectiveness and safety of trastuzumab-deruxtecan, including measures like overall survival, progression-free survival, and tumor response rate. Selected institutions will participate in gathering clinical data. For patients who have passed away or are no longer visiting due to hospice care, data will be collected without consent until August 19, 2024. For patients currently receiving or scheduled to receive trastuzumab-deruxtecan treatment, or those who experienced disease progression and are now receiving subsequent chemotherapy, data collection with consent will continue until March 31, 2027. Participants will be monitored for treatment outcomes such as progression-free survival over one year, overall survival, and tumor responses. Data collection will include clinical information from medical records. The study aims to gather comprehensive real-world evidence on the use of trastuzumab-deruxtecan in this patient group over several years to better understand its efficacy and safety in routine practice.
CONDITIONS
Official 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/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
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
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1
2
3
Trial Site Locations
Total: 1 location
1
minkyu Jung
Seoul, Seoul, South Korea, 03722
Actively Recruiting
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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
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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