NCT05034887

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, enrolled Phase 2 Last updated 8 April 2026

What this trial tests

Phase 2 trial testing Trastuzumab Deruxtecan (T-DXd) monotherapy in Gastric Adenocarcinoma in 64 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

31 January 2022

Primary endpoint
31 March 2028

31 March 2029

Quick facts

Lead sponsor	National Cancer Center Hospital East
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	64
Start date	31 January 2022
Primary completion	31 March 2028
Estimated completion	31 March 2029
Sites	1 location across Japan

Drugs / interventions tested

• Trastuzumab Deruxtecan (T-DXd) monotherapy — full drug profile →
• T-DXd, Durvalumab and Capecitabine Combination — full drug profile →

Conditions studied

• Gastric Adenocarcinoma — all drugs for Gastric Adenocarcinoma →
• Gastroesophageal Junction Adenocarcinoma — all drugs for Gastroesophageal Junction Adenocarcinoma →

Sponsor

National Cancer Center Hospital East

Who can join

20 and older, any sex, with Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Emerging Targeted Therapies for HER2-Positive Breast Cancer.
   Mercogliano MF, Bruni S, Mauro FL, Schillaci R. · · 2023 · cited 95× · PMID 37046648 · DOI 10.3390/cancers15071987
2. HER2-Positive Gastric Cancer and Antibody Treatment: State of the Art and Future Developments.
   Scheck MK, Hofheinz RD, Lorenzen S. · · 2024 · cited 28× · PMID 38611014 · DOI 10.3390/cancers16071336
3. HER2 Inhibition in Gastric Cancer-Novel Therapeutic Approaches for an Established Target.
   Fong C, Chau I. · · 2022 · cited 12× · PMID 35954487 · DOI 10.3390/cancers14153824
4. Perioperative Tailored Treatments for Gastric Cancer: Times Are Changing.
   Lavacchi D, Fancelli S, Buttitta E, Vannini G, et al · · 2023 · cited 11× · PMID 36902306 · DOI 10.3390/ijms24054877
5. Treatment strategies for patients with HER2-positive gastric cancer.
   Wang F, Ba Y. · · 2024 · cited 6× · PMID 38318822 · DOI 10.20892/j.issn.2095-3941.2023.0480
6. Perioperative Treatment in Gastric Cancer: A Fast-Changing Field.
   Costa M, Lopes Fernandes C, Magalhães H. · · 2024 · cited 4× · PMID 39682222 · DOI 10.3390/cancers16234036
7. Recent Advances in the Systemic Treatment of Localized Gastroesophageal Cancer.
   Puhr HC, Reiter TJ, Preusser M, Prager GW, et al · · 2023 · cited 4× · PMID 36980786 · DOI 10.3390/cancers15061900
8. Human Epidermal Growth Factor Receptor 2 [HER-2/neu] Amplification and Microsatellite Stable Status in Gastric and Gastroesophageal Adenocarcinoma: Assessing Frequency and Prognostic Implications at the Cancer Institute of Iran.
   Salarvand S, Mohammadi A, Shahsiah R, Bagheri F, et al · · 2025 · cited 1× · PMID 40851424 · DOI 10.1002/cnr2.70314