Real-World Observational Study to Describe Treatment Patterns in Patients With HER2-Positive Loca… (NCT05606094) | Clinical Trial Compass
CompletedNot Applicable
Real-World Observational Study to Describe Treatment Patterns in Patients With HER2-Positive Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer in East Asia
China, Hong Kong, South Korea450 participantsStarted 2023-03-09
Plain-language summary
This study will be conducted to understand real-world treatment patterns, participant characteristics (demographic and clinico-pathological characteristics), clinical outcomes and safety of different treatment regimens, and healthcare resource utilization in East Asia for HER2-positive locally advanced or metastatic gastric or gastroesophageal adenocarcinoma (de novo advanced disease, relapsed/progressed) in a real-world setting.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult participants at the time of 1st LOT (Index Date 1e) initiation - Adult patients ≥18 years old. (Please follow local regulatory requirements if the legal age of consent for study participation is \>18 years old.)
* Participants or next of kin/legal representatives who are willing to provide written informed consent as per the local regulations (if IRB/IEC/EC grants a permission to waive informed consent, it is not necessary).
* Participants who were pathologically and/or clinically diagnosed with locally advanced or metastatic gastric or gastroesophageal adenocarcinoma (de novo advanced disease, relapsed/progressed) since January 1, 2016, and its record is available at the study participating site.
* Participants whose HER2 status were pathologically confirmed HER2-positive (IHC3+ or IHC2+/ISH-positive) before/at the Index Date 2f based on the most recent archived tumor tissue sample to the Date of Diagnosisg, and its record is available at the study participating site.
* Participants who received at least 1 LOT for HER2-positive locally advanced or mGC/GEJC in an advanced setting, and its record is available at study participating site. Trastuzumab or its biosimilar use is not required.
°Progression on or within 6 months post neoadjuvant or adjuvant therapy is counted as "rapid progressor" in a neo-adjuvant/adjuvant setting, and thus equivalent to advanced/metastatic disease failing 1 LOT.
* Participants who have at least 6 months of follow-up …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants Receiving Each Regimen in Each Line of Treatment (LOT)
Timeframe: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
2
Duration of Therapy for Each Regimen
Timeframe: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
3
Reasons for Stopping Treatments in Each Line of Treatment (LOT)
Timeframe: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
4
Treatment Sequencing Pathways
Timeframe: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
5
Percentage of Participants Receiving Locoregional Treatment for Localized Disease and Metastasis (Radiotherapy and/or Surgery)
Timeframe: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months