Clinical Trial

Phase 2 Study of Trastuzumab Deruxtecan in the Neoadjuvant Treatment, or Trastuzumab Deruxtecan Plus Capecitabine Plus Durvalumab(MEDI4736) in the Preoperative and Postoperative Adjuvant Treatment for Patients With HER2 Positive Gastric and Gastroesophageal Junction Adenocarcinoma

Active, Not Recruiting Phase 2
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Summary
This study is an open-label, single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of neoadjuvant chemotherapy with T-DXd monotherapy in patients with HER2-positive gastric cancer. In the combination cohort, the efficacy and safety of neoadjuvant chemotherapy combined with T-DXd, capecitabine, and durvalumab are evaluated.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2021-09-02; most recent amendment 2026-04-06.
Status change: Recruiting → Active, Not Recruiting 2026-04-06
Status change: Not Yet Recruiting → Recruiting 2022-04-05
Trial Details
NCT Number NCT05034887
Lead Sponsor National Cancer Center Hospital East
Collaborators: Daiichi Sankyo Co., Ltd.
Conditions Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
Enrollment 64 participants
Start Date 2022-01-31
Primary Completion 2028-03-31 (estimated)
Study Completion 2029-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-08