Real-world Effectiveness and Safety of Trastuzumab Deruxtecan in Patients With Locally Advanced o… (NCT06846996) | Clinical Trial Compass
RecruitingNot Applicable
Real-world Effectiveness and Safety of Trastuzumab Deruxtecan in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma in China
China260 participantsStarted 2025-02-27
Plain-language summary
Trastuzumab deruxtecan's (T-DXd's) efficacy and safety has been confirmed in traditional clinical trials, there is a lack of real-world evidence, especially among Chinese patients. The objective of this study is to evaluate real-world effectiveness and safety profile of T-DXd by collecting real-world data treating in patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
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
. Participants with pathologically diagnosed locally advanced unresectable or metastatic gastric cancer/gastroesophageal junction adenocarcinoma (GC/GEJA).
. ≥18 years of age at the time of starting the first dose of T-DXd and signing informed consent form (ICF), capable of providing informed consent.
. HER2-positive status (IHC 3+ or IHC 2+/ISH +).
. Received prior anti-cancer treatment regimens according to National Medical Products Administration indication or clinical judgement of physician.
. Decision to newly initiate T-DXd before study ICF signing. If the participants have started the first dose of T-DXd no longer than 21 days before enrollment, they could be enrolled if the signed and dated ICF could be obtained.
Exclusion criteria
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
Real-world Time to Treatment Failure (rwTTF)
Timeframe: T-DXd treatment initiation date (index date) to date of treatment discontinuation due to disease progression, physician decision, adverse events or death, whichever occurs first, up to approximately 2 years
. Participants who at the time of data collection of the study are participating in or have participated in an interventional study that remains blinded.
. Known hypersensitivity to either the drug substances or inactive ingredients in the drug product.
. Judged by the investigator to be unfit to participate in the study.