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

Real-world Effectiveness and Safety of Trastuzumab Deruxtecan in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma in China: A Nation-wide, Multi-center, Prospective, Non-interventional Study

Observational Daiichi Sankyo · NCT06846996

This study is testing how well Trastuzumab Deruxtecan works and how safe it is for people in China with advanced HER2-positive stomach cancer who are already receiving this treatment.

Quick facts

Study typeObservational
Enrollment260 (estimated)
Ages18 Years and up
SexAll
SponsorDaiichi Sankyo Industry-sponsored
Drugs / interventionsTrastuzumab
Locations36 sites (Beijing and 35 other locations)
Trial IDNCT06846996 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with pathologically diagnosed locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who are initiating treatment with T-DXd.

Not a fit: Patients who are pregnant, breastfeeding, or do not meet the inclusion criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness and safety of T-DXd for patients with advanced HER2-positive gastric cancer.

How similar studies have performed: While traditional clinical trials have confirmed T-DXd's efficacy, this study aims to fill the gap in real-world evidence, particularly among Chinese patients, making it a novel approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Beijing and 35 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HER2-positive Gastric CancerHER2-positive Gastroesophageal JunctionHER2-positive gastric cancerHER2-positive gastroesophageal junction
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.