Evaluating the effectiveness and safety of Trastuzumab Deruxtecan in advanced HER2-positive gastric cancer in China

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to gather real-world data on the effectiveness and safety of Trastuzumab Deruxtecan (T-DXd) in patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma. The primary focus is to assess real-world time to treatment failure, while secondary objectives include evaluating treatment-related adverse events and time to next treatment. Participants will be those who have already initiated T-DXd treatment, and data will be collected without administering any additional drugs as part of the study protocol.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Chaoyang Hospital, Capital Medical University
  Beijing, China Recruiting
• Chinese Academy of Medical Sciences Cancer Hospital
  Beijing, China Recruiting
• China-Japan Friendship Hospital
  Beijing, China Recruiting
• Beijing Friendship Hospital,Capital Medical University
  Beijing, China Recruiting
• Peking University First Hospital
  Beijing, China Recruiting
• Beijing Cancer Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Contact for Clinical Trial Information
• Email: CTRinfo_us@daiichisankyo.com
• Phone: 908-992-6400

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• New treatment for HER2-positive gastric cancer using rilvegostomig and chemotherapy

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• Combination treatment for advanced HER2-positive gastric cancer

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  Recruiting at 16 sites Phase 2 Qilu Hospital of Shandong University · Zhengzhou, Henan and 19 other locations · NCT06730373

• Combination therapy of Disitamab Vedotin and Trastuzumab for HER2 positive gastric cancer

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  Recruiting Phase 1/2 Zhejiang Cancer Hospital · Hangzhou, Zhejiang · NCT06572319

• Treatment for HER2-positive gastric and gastroesophageal junction cancer

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  Recruiting at 206 sites Phase 3 Shanghai Henlius Biotech · Anaheim, California and 207 other locations · NCT06532006

• Treatment for HER2-positive gastric cancer after surgery

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  Recruiting Phase 2 Gruppo Oncologico del Nord-Ovest · Milan · NCT06253650

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.