A Multi-center Real-world Efficacy and Safety of Trastuzumab-deruxtecan in Advanced Gastric Cancer
Launched by YONSEI UNIVERSITY · Jan 5, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effectiveness and safety of a treatment called Trastuzumab Deruxtecan, also known as Enhertu, for patients with advanced gastric cancer. The goal is to gather real-world information about how well this treatment works in patients who started using it from September 2022 onward. The trial will include data from patients who have passed away or are receiving hospice care, allowing researchers to better understand the impact of this treatment.
To be eligible for the trial, participants need to be at least 19 years old and have a specific type of gastric cancer that has spread or cannot be surgically removed. Their cancer must show certain characteristics related to a protein called HER2. The trial is looking for patients who have already received Enhertu as a last option after other treatments have not worked. Those who join can expect to have their health monitored and contribute to important research that may help improve treatments for future patients. It's important to note that patients with different types of gastric cancer or those who haven't consented to participate will not be included in the study.
Gender
ALL
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.
About Yonsei University
Yonsei University, a prestigious institution located in South Korea, is renowned for its commitment to advancing medical research and education. As a clinical trial sponsor, Yonsei University leverages its extensive expertise and innovative approaches in various fields of medicine to conduct rigorous clinical trials aimed at improving patient outcomes and advancing healthcare solutions. The university's robust infrastructure, multidisciplinary collaboration, and adherence to ethical standards ensure the integrity and reliability of its research initiatives, making it a key player in the global clinical research landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Seoul, 서울, Korea, Republic Of
Seoul, , Korea, Republic Of
Patients applied
Trial Officials
minkyu Jung
Principal Investigator
Yonsei Cencer center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported