NCT06846996 Real-world Effectiveness and Safety of Trastuzumab Deruxtecan in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma in China
| NCT ID | NCT06846996 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Daiichi Sankyo |
| Condition | HER2-positive Gastric Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 260 participants |
| Start Date | 2025-02-27 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 260 participants in total. It began in 2025-02-27 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Participants must meet all the following inclusion criteria to be eligible for the study: 1. Participants with pathologically diagnosed locally advanced unresectable or metastatic gastric cancer/gastroesophageal junction adenocarcinoma (GC/GEJA). 2. ≥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. 3. HER2-positive status (IHC 3+ or IHC 2+/ISH +). 4. Received prior anti-cancer treatment regimens according to National Medical Products Administration indication or clinical judgement of physician. 5. 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： Participants who meet any of the following criteria will be excluded from the study: 1. Pregnancy or breastfeeding. 2. Participants who at the time of data collection of the study are participating in or have participated in an interventional study that remains blinded. 3. Known hypersensitivity to either the drug substances or inactive ingredients in the drug product. 4. Judged by the investigator to be unfit to participate in the study.
Contact & Investigator
Project Manager
STUDY DIRECTOR
Daiichi Sankyo Co., Ltd.
Frequently Asked Questions
Who can join the NCT06846996 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HER2-positive Gastric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06846996 currently recruiting?
Yes, NCT06846996 is actively recruiting participants. Contact the research team at CTRinfo_us@daiichisankyo.com for enrollment information.
Where is the NCT06846996 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Beijing, China, Beijing, China and 11 additional locations.
Who is sponsoring the NCT06846996 clinical trial?
NCT06846996 is sponsored by Daiichi Sankyo. The principal investigator is Project Manager at Daiichi Sankyo Co., Ltd.. The trial plans to enroll 260 participants.
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