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Gastric AdenocarcinomaPhase 2NCT05034887

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

A Phase 2 study testing Trastuzumab Deruxtecan (T-DXd) monotherapy and T-DXd, Durvalumab and Capecitabine Combination in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by National Cancer Center Hospital East at 1 site in Japan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Trastuzumab Deruxtecan (T-DXd) monotherapy and T-DXd, Durvalumab and Capecitabine Combination
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteJapan
Study dates
31 Jan 2022to 31 Mar 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction.
  • 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).
  • Have previously untreated gastric and gastroesophageal junction adenocarcinoma and cT2-4 and/or cN+M0.according to the UICC TNM classification (8th edition),
  • Age ≥ 20 years as the day of informed consent.
  • Has an ECOG performance status (PS) of 0 or 1.
  • 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).
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  • 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]
  • 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
  • Has a treatment-free period from the end of pre-treatment to before enrollment (allowed on the same day of the week), defined as:
  • 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).
  • Chloroquine and hydroxychloroquine : ≧ 15 days
  • 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.
  • 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").
  • Written informed consent of participation in the study has been obtained from the patient.

Who cannot join

  • 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.
  • 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.]
  • 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.).
  • Has history of gastrointestinal perforation and/or gastrointestinal fistula within 6 months before enrollment.
  • Has any of the following infections:
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  • 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.
  • HIV infection
  • 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.
  • Has history of concomitant autoimmune disease or chronic or recurrent autoimmune disease.
  • 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.
  • Has unhealed wounds, ulcers, or fractures.
  • If patients are a pregnancy or breastfeeding patient.
  • Has documented severe hypersensitivity to study drug active ingredients or additives.
  • Has history/complications of severe hypersensitivity reactions to other monoclonal antibodies.
  • has uncontrolled acute systemic infection that requires Infusion intravenous antibiotic, antiviral, or antifungal drug.
  • Unwilling or unable to follow study protocol or any of the instructions by the physician.
  • The investigator or subinvestigator considered it ineligible for the study.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • National Cancer Center Hospital East

    Kashiwa, Chiba

Other trials in Japan

About this study

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.

Read the detailed description

This study is an open-label, single-arm, multicenter, phase 2 clinical trial. Eligible patients are with previously untreated gastric and gastroesophageal junction adenocarcinoma as defined by cT2-4 and/or cN+ without evidence of metastatic disease. Study treatment in this study is neoadjuvant treatment with the investigational drug, T-DXd alone, followed by surgery. T-DXd will be administered at a dose of 6.4 mg/kg (decimal) by intravenous infusion every 21 days (3 weeks) for 3 cycles as the neoadjuvant treatment followed by surgery.

In the combination cohort, the efficacy and safety of neoadjuvant chemotherapy combined with T-DXd, capecitabine, and durvalumab are evaluated.

T-DXd 5.4 mg/kg and Durvalumab 1500 mg were infused intravenously once 3 weeks, and Capecitabine 750 mg/m2 was administered orally twice daily for 14 days with a 7-day rest period. T-DXd, Capecitabine, and Durvalumab were repeated 3 cycles preoperatively and 3 cycles postoperatively, followed by 10 cycles of Durvalumab monotherapy every 4 weeks.

Monotherapy will be analyzed in the following 2 analysis sets.

  • Patients with HER2 overexpression (IHC3+ or IHC2+ and ISH-positive [FISH or DISH]) in the primary lesion or metastasis (primary analysis part)
  • Patients with low expression of HER2 (IHC1+ or IHC2+ and negative for ISH [FISH or DISH]) and HER2-ECD > 11.6 ng/mL in the primary lesion or metastasis (exploratory part)

The combination cohort will be analyzed in the following analysis sets.

  • Patients with HER2 overexpression (IHC3+ or IHC2+ and ISH-positive [FISH or DISH]) in the primary lesion or metastasis with gastric adenocarcinoma or GEJ adenocarcinoma
Being tested
Trastuzumab Deruxtecan (T-DXd) monotherapy, T-DXd, Durvalumab and Capecitabine Combination
Keywords
Trastuzumab Deruxtecan T-DXd DS-8201a Gastric cancer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trastuzumab Deruxtecan (T-DXd) monotherapyDrug

    Also called DS-8201a

    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.

  • T-DXd, Durvalumab and Capecitabine CombinationDrug

    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.

Study groups in NCT05034887
Study groupRoleWhat they receive
Trastuzumab Deruxtecan (T-DXd) monotherapyExperimentalOne cycle is 21 days, with T-DXd repeated 3 cycles before surgery as the neo adjuvant treatment.
Receives: Drug: Trastuzumab Deruxtecan (T-DXd) monotherapy
Combination cohortExperimentalT-DXd 5.4 mg/kg and Durvalumab 1500 mg were infused intravenously once 3 weeks, and Capecitabine 750 mg/m2 was administered orally twice daily for 14 days with a 7-day rest period. T-DXd, Capecitabine, and Durvalumab were repeated 3 cycles preoperatively and 3 cycles postoperatively, followed by 10 cycles of Durvalumab monotherapy every 4 weeks.
Receives: Drug: T-DXd, Durvalumab and Capecitabine Combination

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major pathological response [MPR] rate: by central assessment

    MPR is defined as the proportion of subjects with < 10% residual tumor in the stomach and lymph nodes by central assessment

    Measured: 6 months

Secondary outcomes (8)

  1. MPR rate determined by the local assessment

    The proportion of subjects with MPR by Local assessment

    Measured: 6 months

  2. Pathological complete response (pCR) rate

    The proportion of subjects with complete remission of gastric and lymph node tumors by local assessment

    Measured: 6 months

  3. Curative Resection Rate

    Defined as the proportion of subjects who start study treatment and undergo radical resection (R0)

    Measured: 6 months

  4. AE rate

    The treatment-emergent AEs will be summarized by CTCAE v5.0.

    Measured: From the start day of study treatment, "47 days after the last dose, 30 days after surgery, or if postoperative adjuvant chemotherapy or treatment is started before it, whichever comes first.

  5. Percentage of completed treatment before surgery (Combination cohort only)

    The proportion of subjects who underwent radical resection (R0) after the initiation of the study treatment and the completion of the 3 cycles of the study treatment is defined as the proportion of subjects who underwent radical resection (R0).

    Measured: 3 years

  6. Percentage of completed postoperative adjuvant chemotherapy (Combination cohort only)

    The proportion of subjects who received 3 cycles of the study drug until radical resection (R0) and received 13 cycles of adjuvant chemotherapy after the initiation of the study treatment.

    Measured: 3 years

  7. Event-Free Survival (EFS) (Combination cohort only)

    The date of registration is defined as the start date and the time to the event that occurred whichever comes first:

    • Disease progression based on imaging evaluations using RECIST 1.1
    • Local or distant recurrence based on CT or biopsy in patients without postoperative lesions
    • Death from any cause

    Measured: 3 years

  8. Overall Survival (OS) (Combination cohort only)

    The date of registration is defined as the start date and the time to death from any cause is defined as the period from the start date of registration.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2021
  2. Study start31 Jan 2022
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05034887
Sponsor's protocol ID
EPOC2003
Status last verified
Apr 2026
First submitted
2 Sep 2021
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trastuzumab Deruxtecan (T-DXd) monotherapy and T-DXd, Durvalumab and Capecitabine Combination in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by National Cancer Center Hospital East at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major pathological response [MPR] rate: by central assessment (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05034887.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.

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