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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

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 (NCT05034887) is a Phase 2 interventional studying Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, sponsored by National Cancer Center Hospital East. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Gastric Adenocarcinoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 64 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Gastric Adenocarcinoma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. diagnosed by tissue sample (biopsy-confirmed) adenocarcinoma of the gastric or gastroesophageal junction. 2. Has HER2 overexpression (IHC3+, or IHC2+ and ISH positive \[FISH or DISH\]). (HER2 Low expression: IHC1+, or IHC2+ and ISH-negative \[FISH or DISH\] with HER2-ECD \> 11.6 ng/mL in the exploratory cohort). 3. Have previously untreated gastric and gastroesophageal junction adenocarcinoma and cT2-4 and/or cN+M0.according to the UICC TNM classification (8th edition), 4. Age ≥ 20 years as the day of willing to sign a consent form. 5. Has an ECOG performance status (PS) of 0 or 1. 6. Has a left ventricular ejection fraction (LVEF) ≥ 50% by either echocardiogram (ECHO) or multigated collecting acquisition (MUGA) scan within 28 days before enrollment (acceptable on the same day of the week). 7. Has a corrected QT interval (QTc) ≦ 470 ms in females, or QTc ≦ 450 ms in males based on a 12-lead ECG screening within 28 days before enrollment (allowed on the same day of the week). \[Fridericia's correction is recommended\] 8. Satisfies all of the following requirements within 14 days before enrollment (allowed on the same day of the week). - Absolute neutrophil count ≧1500 / mm3 \[except for assessment ≦ 14 days after administration of Granules colony-stimulating factors (G-CSF)\] - Hemoglobin ≧ 8.0 g/dL (except for those measured within 7 days after whole blood transfusion or packed red blood cells) - Platelet count ≧100000 per mm3 (excluding measurements within 7 days after platelet transfusion). - Total bilirubin ≦1.5 mg/dL (patients with gilbert's syndrome will be allowed if they have \< 3.0 mg/dL). - AST(GOT)≦100 IU/L - ALT(GPT)≦100 IU/L - Serum albumin ≧ 2.5 g/dL - Calculated creatinine clearance (Cockcroft-Gault *) or the actual value ≧ 30 mL/min * Cockcroft-Gault equation: creatinine clearance= (140 - age) × body weight (kg) / (72 × Serum creatinine) (\* 0.85 x the value obtained for females). - PT(INR)\< 1.8 - aPTT \< 60 seconds ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction. 2. Has HER2 overexpression (IHC3+, or IHC2+ and ISH positive \[FISH or DISH\]). (HER2 Low expression: IHC1+, or IHC2+ and ISH-negative \[FISH or DISH\] with HER2-ECD \> 11.6 ng/mL in the exploratory cohort). 3. Have previously untreated gastric and gastroesophageal junction adenocarcinoma and cT2-4 and/or cN+M0.according to the UICC TNM classification (8th edition), 4. Age ≥ 20 years as the day of informed consent. 5. Has an ECOG performance status (PS) of 0 or 1. 6. Has a left ventricular ejection fraction (LVEF) ≥ 50% by either echocardiogram (ECHO) or multigated collecting acquisition (MUGA) scan within 28 days before enrollment (acceptable on the same day of the week). 7. Has a corrected QT interval (QTc) ≦ 470 ms in females, or QTc ≦ 450 ms in males based on a 12-lead ECG screening within 28 days before enrollment (allowed on the same day of the week). \[Fridericia's correction is recommended\] 8. Satisfies all of the following requirements within 14 days before enrollment (allowed on the same day of the week). * Absolute neutrophil count ≧1500 / mm3 \[except for assessment ≦ 14 days after administration of Granules colony-stimulating factors (G-CSF)\] * Hemoglobin ≧ 8.0 g/dL (except for those measured within 7 days after whole blood transfusion or packed red blood cells) * Platelet count ≧100000 per mm3 (excluding measurements within 7 days after platelet transfusion). * Total bilirubin ≦1.5 mg/dL (patients with gilbert's syndrome will be allowed if they have \< 3.0 mg/dL). * AST(GOT)≦100 IU/L * ALT(GPT)≦100 IU/L * Serum albumin ≧ 2.5 g/dL * Calculated creatinine clearance (Cockcroft-Gault *) or the actual value ≧ 30 mL/min * Cockcroft-Gault equation: creatinine clearance= (140 - age) × body weight (kg) / (72 × Serum creatinine) (\* 0.85 x the value obtained for females). * PT(INR)\< 1.8 * aPTT \< 60 seconds 9. Has a treatment-free period from the end of pre-treatment to before enrollment (allowed on the same day of the week), defined as: i. Surgery with general anesthesia : ≧ 4 weeks ii. Radiotherapy: ≧ 4 weeks (including palliative stereotactic body radiation therapy to the chest; palliative stereotactic body radiation therapy to other than the chest ≧ 2 weeks; abdominal vertebral bodies should be included in the abdomen). iii. Chloroquine and hydroxychloroquine : ≧ 15 days 10. Has a prior radiotherapy or surgical AE recovered of ≦ Grade 1 or ≦ baseline on CTCAE v5.0. However, this shall not apply to events where the symptoms are stable even if they are grade 2 or higher. 11. Female of childbearing potential have a negative pregnancy test within 7 days before enrollment (allowed on the same day of the week). Male and Female of childbearing potential agree to contraception for a period (4 months for male and 7 months for Female) from informed consent to the last dose of study drug (see 4.3 "Pregnancy and contraception"). 12. Written informed consent of participation in the study has been obtained from the patient. Exclusion Criteria: 1. Has a medical history of myocardial infarction or congestive heart failure (New York Heart Association Classes II-IV) within 6 months before enrollment, corresponding to the value diagnosed as myocardial infarction as defined by the \*validated test within 28 days before enrollment (allowed on the same day), unstable angina, or any serious arrhythmia requiring treatment. * tested in local institutions \*\*: Enrollment is allowed with value exceeds ULN if myocardial infarction can be excluded. 2. Active other cancers \[Synchronous other cancers and metachronous other cancers within 3 years prior to enrollment, but carcinoma in situ or other lesions corresponding to mucosal carcinoma that are considered curable with local treatment will not be included in active other cancers.\] 3. Has serious (hospitalized) complications (intestinal palsy, intestinal obstruction, pulmonary fibrosis, diabetes mellitus that is difficult to control, heart failure, myocardial infarction, unstable angina, renal failure, liver failure, psychiatric disorders, cerebrovascular disorders, etc.). 4. Has history of gastrointestinal perforation and/or gastrointestinal fistula within 6 months before enrollment. 5. Has any of the following infections: * HBs antigen positive * HBs antibody or HBc antibody and HBV-DNA positive * Active hepatitis C (eg, if HCV RNA is detected qualitatively) Patients who are HBsAg positive but who have achieved HBV DNA level \< 1.3 log IU/mL (2.1 log copies/mL) after treatment with antiviral drugs such as NAs, are eligible for the study. 6. HIV infection 7. Lung diseases defined as: * Has a history of non-infectious interstitial lung disease or pneumonitis that required treatment, has interstitial lung disease or pneumonitis, or these lung diseases cannot be ruled out by radiographic examination before enrollment. * Severe pulmonary disease (eg, pulmonary embolism within 3 months prior to enrollment, serious bronchial asthma, severe COPD, restrictive pulmonary disease, or pleural effusion). Lung-related autoimmune or connective tissue or inflammatory diseases (eg, rheumatoid arthritis, Sjögren's syndrome, or sarcoidosis) with clinically severe pulmonary risks. • Has history of pneumonectomy. 8. Has history of concomitant autoimmune disease or chronic or recurrent autoimmune disease. 9. Administration of systemic corticosteroids (except prophylactic administration for diagnostic tests or allergic reactions, and temporary use for the purpose of reducing edema associated with radiotherapy) or immunosuppressants is required, or has received these treatments within 14 days before enrollment in the study. 10. Has unhealed wounds, ulcers, or fractures. 11. If patients are a pregnancy or breastfeeding patient. 12. Has documented severe hypersensitivity to study drug active ingredients or additives. 13. Has history/complications of severe hypersensitivity reactions to other monoclonal antibodies. 14. has uncontrolled acute systemic infection that requires Infusion intravenous antibiotic, antiviral, or antifungal drug. 15. Unwilling or unable to follow study protocol or any of the instructions by the physician. 16. The investigator or subinvestigator considered it ineligible for the study.

Treatments Being Tested

DRUG

Trastuzumab Deruxtecan (T-DXd) monotherapy

T-DXd will be administered at a dose of 6.4 mg/kg (decimal) by intravenous infusion every 21 days (3 weeks) for subsequent three cycles.

DRUG

T-DXd, Durvalumab and Capecitabine Combination

Administer each cycle over 21 days. T-DXd is administered by intravenous infusion at 5.4 mg/kg every 21 days (every 3 weeks). Capecitabine is given at 750 mg/m2 BID, taken orally for 14 days, followed by a drug holiday from the evening of Day 15 to the morning of Day 22 (Day 1 of the next cycle). Durvalumab is administered at 1500 mg by intravenous infusion over 60 minutes every 21 days (every 3 weeks). As neoadjuvant chemotherapy, administer T-DXd, Capecitabine, and Durvalumab in combination on a q3w schedule for 3 cycles. As adjuvant chemotherapy consists of T-DXd, Capecitabine, and Durvalumab in combination on a q3w schedule for 3 cycles, followed by Durvalumab monotherapy on a q4w schedule until 10 cycles are completed.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

National Cancer Center Hospital East
Kashiwa, Chiba, Japan

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05034887), the sponsor (National Cancer Center Hospital East), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05034887 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05034887?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05034887?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05034887. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05034887. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.