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Gastric CancerPhase 2NCT07911280

A Phase II, Trial of Neoadjuvant Trastuzumab + Durvalumab + FLOT Targeted Immunochemotherapy

A Phase 2 study testing Trastuzumab + Durvalumab + FLOT in people with Gastric Cancer, run by Samsung Medical Center at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Treatment and Treatment Duration Neoadjuvant chemotherapy will begin on Day 1 of Cycle 1 and will be administered every 2 weeks for a total of 4 cycles. After surgery, XELOX, which is currently used as standard adjuvant chemotherapy, will be administered for 6-8 cycles at the physician's discretion. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Gastric Cancer
What is being tested?
Trastuzumab + Durvalumab + FLOT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSouth Korea
Study dates
6 Oct 2026to 31 Dec 2030
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

  • 1. The subject must provide written informed consent prior to any study-specific procedures after receiving adequate information regarding the study.
  • 2. The subject must be ≥19 years of age. 3. Body weight >30 kg. 4. Histologically documented adenocarcinoma of the stomach or gastroesophageal junction (GEJ) with available HER2 IHC results.
  • 5. Confirmed HER2-positive disease, defined as HER2 IHC 3+ or HER2 IHC 2+/SISH-positive.
  • 6. Locally advanced, resectable gastric or gastroesophageal junction cancer as determined by the investigator (e.g., cT2 or higher and/or node-positive disease), with no unequivocal distant organ metastasis and for whom perioperative treatment is considered indicated.
  • 7. ECOG performance status of 0-1, with no deterioration between screening and the first dose of study treatment.
  • 8. Left ventricular ejection fraction (LVEF) ≥50% as assessed by echocardiography (ECHO) within 28 days prior to treatment.
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  • 9. Measurable target disease as assessed by the investigator according to modified RECIST version 1.1.
  • 10. Adequate organ, bone marrow, hepatic, and renal function within 28 days prior to treatment.
  • Note: No transfusion of red blood cells or platelets and no administration of G-CSF are permitted from 14 days prior to assessment of bone marrow function through C1D1.
  • Hemoglobin ≥9.0 g/dL (≥8.0 g/dL for the gastric cancer indication)
  • Platelet count ≥100 × 10⁹/L
  • Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L
  • Total bilirubin ≤1.5 × ULN, except in patients with documented Gilbert syndrome (unconjugated hyperbilirubinemia), for whom <3 × ULN is acceptable
  • AST (SGOT)/ALT (SGPT) ≤3.0 × ULN
  • Serum albumin ≥2.5 g/dL
  • Creatinine clearance (CrCL/Ccr) ≥30 mL/min, calculated using the Cockcroft-Gault formula with actual body weight
  • INR, PT, or APTT ≤1.5 × ULN 11. Female subjects must use a highly effective method of contraception throughout the study and for 15 months after permanent discontinuation of the study drugs, including the agents used in neoadjuvant and postoperative adjuvant treatment. The overall contraception period has been aligned with the locally approved labeling for oxaliplatin, which recommends contraception for 15 months in women of childbearing potential. If the most recent local prescribing information for any study drug specifies a longer contraception period, that requirement will take precedence.
  • At screening, there must be evidence that the patient is not breastfeeding and is either not of childbearing potential or has a negative pregnancy test, as defined by at least one of the following:
  • Postmenopausal status, defined as age ≥50 years and amenorrhea for at least 12 months after cessation of all exogenous hormonal therapy
  • Documented irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy; tubal ligation alone is not sufficient
  • Amenorrhea for 12 months with serum FSH, LH, and plasma estradiol levels within the institution's postmenopausal range Further details are provided in Appendix F (Definition and Acceptable Methods of Contraception for Women of Childbearing Potential).
  • Female subjects must not breastfeed and must not donate or retrieve ova from screening until 60 days after the last dose.
  • 12. Male subjects who are sexually active with a female partner of childbearing potential and who have not undergone sterilization must use a condom with spermicide from screening until 12 months after the final dose of study treatment.
  • Complete heterosexual abstinence during the study and drug washout period is acceptable if this is consistent with the patient's usual and preferred lifestyle. Periodic abstinence, calendar/rhythm methods, and withdrawal are not acceptable methods of contraception.
  • Female partners of male subjects are strongly encouraged to use at least one highly effective method of contraception throughout this period.
  • Male subjects must also refrain from fathering a child and from cryopreserving or donating sperm from enrollment through the study period and for 12 months after the final dose of study treatment. If the latest local prescribing information for any study drug specifies a longer contraception period, that requirement will take precedence.
  • The subject must provide written informed consent prior to any study-specific procedures after receiving adequate information regarding the study.
  • The subject must be ≥19 years of age.
  • Body weight >30 kg.
  • Histologically documented adenocarcinoma of the stomach or gastroesophageal junction (GEJ) with available HER2 IHC results.
  • Confirmed HER2-positive disease, defined as HER2 IHC 3+ or HER2 IHC 2+/SISH-positive.
  • Locally advanced, resectable gastric or gastroesophageal junction cancer as determined by the investigator (e.g., cT2 or higher and/or node-positive disease), with no unequivocal distant organ metastasis and for whom perioperative treatment is considered indicated.
  • ECOG performance status of 0-1, with no deterioration between screening and the first dose of study treatment.
  • Left ventricular ejection fraction (LVEF) ≥50% as assessed by echocardiography (ECHO) within 28 days prior to treatment.
  • Measurable target disease as assessed by the investigator according to modified RECIST version 1.1.
  • Adequate organ, bone marrow, hepatic, and renal function within 28 days prior to treatment.
  • Note: No transfusion of red blood cells or platelets and no administration of G-CSF are permitted from 14 days prior to assessment of bone marrow function through C1D1.
  • Hemoglobin ≥9.0 g/dL (≥8.0 g/dL for the gastric cancer indication)
  • Platelet count ≥100 × 10⁹/L
  • Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L
  • Total bilirubin ≤1.5 × ULN, except in patients with documented Gilbert syndrome (unconjugated hyperbilirubinemia), for whom <3 × ULN is acceptable
  • AST (SGOT)/ALT (SGPT) ≤3.0 × ULN
  • Serum albumin ≥2.5 g/dL
  • Creatinine clearance (CrCL/Ccr) ≥30 mL/min, calculated using the Cockcroft-Gault formula with actual body weight
  • INR, PT, or APTT ≤1.5 × ULN
  • Female subjects must use a highly effective method of contraception throughout the study and for 15 months after permanent discontinuation of the study drugs, including the agents used in neoadjuvant and postoperative adjuvant treatment. The overall contraception period has been aligned with the locally approved labeling for oxaliplatin, which recommends contraception for 15 months in women of childbearing potential. If the most recent local prescribing information for any study drug specifies a longer contraception period, that requirement will take precedence.
  • At screening, there must be evidence that the patient is not breastfeeding and is either not of childbearing potential or has a negative pregnancy test, as defined by at least one of the following:
  • Postmenopausal status, defined as age ≥50 years and amenorrhea for at least 12 months after cessation of all exogenous hormonal therapy
  • Documented irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy; tubal ligation alone is not sufficient
  • Amenorrhea for 12 months with serum FSH, LH, and plasma estradiol levels within the institution's postmenopausal range Further details are provided in Appendix F (Definition and Acceptable Methods of Contraception for Women of Childbearing Potential).
  • Female subjects must not breastfeed and must not donate or retrieve ova from screening until 60 days after the last dose.
  • Male subjects who are sexually active with a female partner of childbearing potential and who have not undergone sterilization must use a condom with spermicide from screening until 12 months after the final dose of study treatment.
  • Complete heterosexual abstinence during the study and drug washout period is acceptable if this is consistent with the patient's usual and preferred lifestyle. Periodic abstinence, calendar/rhythm methods, and withdrawal are not acceptable methods of contraception.
  • Female partners of male subjects are strongly encouraged to use at least one highly effective method of contraception throughout this period.
  • Male subjects must also refrain from fathering a child and from cryopreserving or donating sperm from enrollment through the study period and for 12 months after the final dose of study treatment. If the latest local prescribing information for any study drug specifies a longer contraception period, that requirement will take precedence.

Who cannot join

  • Patients with unequivocal peritoneal metastasis, including malignant cells detected in peritoneal fluid, or with distant metastasis.
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency. DPD deficiency must be assessed according to applicable local and/or institutional requirements.
  • Uncontrolled intercurrent illness, including but not limited to ongoing or active infection, uncontrolled hypertension, significant chronic gastrointestinal disease associated with diarrhea, or psychiatric illness/social circumstances that would limit study compliance, significantly increase the risk of adverse events, or impair the patient's ability to provide written informed consent.
  • Unresolved toxicity of Grade ≥2 according to CTCAE v5.0 from prior therapy, except for vitiligo, alopecia, endocrine disorders controlled with hormone replacement therapy, or asymptomatic laboratory abnormalities.
  • History of organ transplantation.
  • Active primary immunodeficiency, a history of active primary immunodeficiency, or active infectious disease.
Show all 67Show fewer
  • Active or previously documented autoimmune or inflammatory disorders at screening, including but not limited to:
  • inflammatory bowel disease (IBD; e.g., Crohn's disease, ulcerative colitis, or diverticulitis)
  • systemic lupus erythematosus (SLE)
  • sarcoidosis syndrome
  • tuberculosis
  • Wegener's syndrome
  • myasthenia gravis
  • Graves' disease
  • rheumatoid arthritis
  • hypophysitis
  • uveitis For studies involving known hepatotoxicity or other relevant risks, consideration should also be given to a history of organ transplantation requiring immunosuppressive therapy within the previous 2 years, glomerulonephritis, nephrotic syndrome, Fanconi syndrome, or renal tubular acidosis.
  • Exceptions include:
  • Subjects with vitiligo, alopecia, hypothyroidism stable on hormone replacement therapy (e.g., following Hashimoto syndrome), psoriasis not requiring systemic treatment, or celiac disease controlled by diet alone
  • Subjects with no active disease within the previous 5 years may be eligible after consultation with the principal investigator
  • HBsAg carriers without active viral infection who are receiving entecavir prophylaxis may be eligible
  • History of interstitial lung disease (ILD)/pneumonitis requiring steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be excluded by screening imaging.
  • Active hepatitis B (HBsAg-positive) or active hepatitis C. Viral quantification is not mandatory for study eligibility. Patients with prior or resolved HBV or HCV infection may be eligible.
  • Note: If HBsAg-negative, patients must have discontinued antiviral therapy for at least 6 months.
  • Subjects with prior or resolved HBV infection are eligible only if all of the following criteria are met:
  • anti-HBc positive (IgG or total Ig)
  • HBV DNA undetectable
  • no evidence of cirrhosis or fibrosis on prior imaging or biopsy
  • no concurrent or prior HCV infection
  • access to a local hepatitis B specialist during and after the study These subjects should be closely monitored for HBV reactivation. If the comparator treatment or combination study treatment carries a high risk of HBV reactivation and is incompatible with antiviral therapy, exclusion of all subjects with HBV infection should be considered.
  • Known positive test for human immunodeficiency virus (HIV; HIV-1/2 antibody-positive) or active tuberculosis infection based on clinical history, physical examination, radiographic findings, or local testing practice.
  • Subjects with poorly controlled HIV infection are excluded. Well-controlled HIV infection requires all of the following:
  • undetectable viral RNA
  • CD4+ count ≥350 cells/μL
  • no history of AIDS-defining opportunistic infection within the previous 12 months
  • stable on the same antiretroviral regimen for at least 4 weeks, with no anticipated change in the number or type of antiretroviral agents If these criteria are met, monitoring of viral RNA load and CD4+ count is recommended. HIV testing may be performed if permitted by local regulations or the institutional IRB/IEC.
  • Patients meeting any of the following cardiac criteria:
  • Mean corrected QT interval using Fridericia's correction (QTcF ≥470 ms)
  • Any clinically significant abnormality in rhythm, conduction, or morphology on resting ECG, such as complete left bundle branch block, third-degree heart block, second-degree heart block, or PR interval >250 ms
  • Any factor increasing the risk of QT prolongation or arrhythmic events, including heart failure, uncorrectable chronic hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death before age 40 in a first-degree relative, or concomitant medications known to prolong the QT interval
  • Uncontrolled hypotension, defined as systolic BP <90 mmHg and/or diastolic BP <60 mmHg, or clinically relevant orthostatic hypotension including a ≥20 mmHg decrease in blood pressure
  • Atrial fibrillation with resting ventricular rate >100 bpm
  • Symptomatic heart failure (NYHA Class II-IV)
  • Symptomatic congestive heart failure (NYHA Class II-IV)
  • Known LVEF <50%
  • Previous or current cardiomyopathy of any etiology
  • Previous or current acute myocardial infarction within the past 6 months
  • Severe valvular heart disease
  • Uncontrolled angina despite medical therapy (Canadian Cardiovascular Society Class II-IV)
  • Stroke or transient ischemic attack prior to screening
  • Acute coronary syndrome within 6 months prior to treatment initiation
  • Pregnant or breastfeeding women, or male or female subjects of childbearing potential who are unwilling to use effective contraception from screening until the specified period after the final dose of each study treatment, including trastuzumab, FLOT, durvalumab, and postoperative adjuvant XELOX:
  • 15 months for women of childbearing potential
  • 12 months for men These requirements are consistent with the inclusion criteria.
  • Known allergy or hypersensitivity to any study drug or any of its excipients.
  • Any of the following within 14 days prior to the first dose:
  • Current or prior significant chronic gastrointestinal disease associated with diarrhea, such as active inflammatory bowel disease
  • Active noninfectious skin disorder requiring systemic treatment, including rash, urticaria, dermatitis, ulceration, or psoriasis of any grade
  • Active or previously documented autoimmune or inflammatory disease requiring chronic treatment with steroids or other immunosuppressive therapy
  • Exceptions include:
  • Intranasal, inhaled, topical corticosteroids, or local corticosteroid injections (e.g., intra-articular injection)
  • Systemic corticosteroids at physiologic doses not exceeding prednisone 10 mg/day or equivalent
  • Steroids used as premedication for hypersensitivity or infusion-related reactions
  • Receipt of a live attenuated vaccine within 30 days prior to the first dose of study intervention.
  • Note: Subjects must not receive live vaccines while receiving study intervention and for 30 days after the final dose of study intervention.
  • Peripheral neuropathy of CTCAE Grade ≥2 at screening.
  • Patients with hereditary conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kyung Han Na Na, RN contact

+82-2-2148-9848

kyunghan.na@sbri.co.kr

South Korea1 site, 1 recruiting
  • Samsung Medical Center

    Seoul, Gang-Nam

    Kyung Han Na, RN, +82-2-2148-9848, kyunghan.na@sbri.co.kr

    Recruiting

Other trials in South Korea

About this study

Official title: A Phase II, Single-Center Platform Trial of Neoadjuvant Trastuzumab + Durvalumab + FLOT Targeted Immunochemotherapy in Patients With Locally Advanced, Resectable HER2-Positive Gastric or Gastroesophageal Junction Cancer

Treatment and Treatment Duration Neoadjuvant chemotherapy will begin on Day 1 of Cycle 1 and will be administered every 2 weeks for a total of 4 cycles.

After surgery, XELOX, which is currently used as standard adjuvant chemotherapy, will be administered for 6-8 cycles at the physician's discretion.

Read more

Study Duration The study duration is expected to be approximately 3 years from the date of IRB approval.

(The study duration may be subject to change depending on the enrollment rate.) Number of Subjects The target enrollment for this study is 20 subjects. Investigational Products, Dose, and Route of Administration Neoadjuvant chemotherapy will begin on Day 1 of Cycle 1 and will be administered every 2 weeks for a total of 4 cycles.

Neoadjuvant Therapy

  • One cycle: 2 weeks (14 days)
  • Total treatment duration: 4 cycles, approximately 8 weeks
  • CnD1
  • Trastuzumab 4 mg/kg IV Q2W
  • Trastuzumab 6 mg/kg IV on C1D1 only
  • Durvalumab 1,500 mg IV Q4W
  • Administered on C2D1 and C4D1 only
  • FLOT regimen
  • Docetaxel 50 mg/m² IV Q2W
  • Oxaliplatin 85 mg/m² IV Q2W
  • Leucovorin 200 mg/m² IV Q2W
  • 5-FU 2,600 mg/m² as a 24-hour continuous IV infusion Q2W After surgery, XELOX, which is currently used as standard adjuvant chemotherapy, will be administered for 6-8 cycles at the physician's discretion.

Adjuvant Chemotherapy

  • One cycle: 3 weeks (21 days)
  • Total treatment duration: 4 cycles, with treatment extendable up to 6 cycles at the investigator's discretion, corresponding to approximately 12-18 weeks
  • Day 1: Oxaliplatin 130 mg/m² IV Q3W
  • Days 1-14: Capecitabine 1,000 mg/m² PO BID Q3W
Read the detailed description

The primary endpoint of this study is the pathologic complete response (pCR) rate. For the pCR rate, the null hypothesis (H0: P ≤ 15%) and the alternative hypothesis (H1: P ≥ 40%) were tested using a one-sided type I error of 0.05 and 80% power. Based on this calculation, 19 evaluable subjects were required. Allowing for a 5% dropout rate, the planned enrollment was set at 20 subjects.

Among the study endpoints, safety and toxicity, as well as the secondary endpoints-including overall response rate, R0 resection rate, overall survival (OS), Becker tumor regression grade (TRG1a/b), surgery-related morbidity and mortality, feasibility, and safety [adverse events according to NCI CTCAE v5.0]-will be analyzed descriptively. Survival-related outcomes will be estimated using the Kaplan-Meier method.

All analyses will be performed based on the data actually available. Missing time-to-event data will be treated as censored, whereas missing data for the primary endpoint will be considered treatment failures. Confidence intervals (CIs) for the pathologic response rate will be calculated using the Clopper-Pearson method.

Prism version 9.5.1 will be used for CI calculations. All other endpoints will be analyzed using SAS software version 9.4 or later (SAS Institute Inc.) or R version 3.6.1 or later (R Foundation for Statistical Computing).

Conditions
Gastric Cancer
Being tested
Trastuzumab + Durvalumab + FLOT
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • Trastuzumab + Durvalumab + FLOTDrug

    Trastuzumab + Durvalumab + FLOT

Study groups in NCT07911280
Study groupRoleWhat they receive
Trastuzumab + Durvalumab + FLOTExperimentalTrastuzumab + Durvalumab + FLOT
Receives: Drug: Trastuzumab + Durvalumab + FLOT

What is being measured

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

  1. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0

    Evaluation of safety of neoadjuvant FLOT + Trastuzumab + Durvalumab therapy

    Measured: From Cycle 1 Day 1 of neoadjuvant treatment through completion of postoperative adjuvant XELOX (6-8 cycles) Neoadjuvant Chemotherapy - Cycle length: 2 weeks (14 days) - Total duration: 4 cycles (8 weeks) Adjuvant Chemotherapy - Cycle length: 3 weeks (21D

Secondary outcomes (1)
  1. Percentage of Participants Achieving R0 Resection

    The percentage of participants achieving R0 resection following neoadjuvant FLOT plus trastuzumab and durvalumab therapy. R0 resection is defined as complete surgical removal of the tumor with microscopically negative resection margins, as determined by histopathological examination of surgical specimens.

    Measured: At the time of definitive surgery (perioperative)

Timeline

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

  1. First posted2 Nov 2026
  2. Study start6 Oct 2026
  3. Primary completion1 Jan 2030 (estimated)
  4. Study completion31 Dec 2030 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07911280
Sponsor's protocol ID
2026-05-163
Status last verified
Oct 2026
First submitted
7 Oct 2026
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The investigator (sponsor-investigator) will assign a unique identification code to each subject. Subjects must be informed that clinical trial-related data will be used in accordance with applicable local data protection laws. The extent to which the data may be disclosed and used must also be explained to subjects through the informed consent form (ICF). This study will be conducted in accordance with the ethical principles of the Declaration of Helsinki, Korean Good Clinical Practice (KGCP), and applicable regulatory requirements. The final study protocol, including the final version of the written informed consent form, must receive written approval or a favorable opinion from the Institutional Review Board (IRB) before any subject is enrolled in the study. The principal investigator is responsible for notifying the IRB of any protocol amendments and obtaining approval, as required by applicable local requirements.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trastuzumab + Durvalumab + FLOT in people with Gastric Cancer, run by Samsung Medical Center at 1 site in South Korea.

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 55 inclusion and 67 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: looking for participants now, as of the sponsor's last update on 2 Nov 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 South Korea. 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?

Contact Kyung Han Na Na, RN (+82-2-2148-9848, kyunghan.na@sbri.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0 (time frame: From Cycle 1 Day 1 of neoadjuvant treatment through completion of postoperative adjuvant XELOX (6-8 cycles) Neoadjuvant Chemotherapy - Cycle length: 2 weeks (14 days) - Total duration: 4 cycles (8 weeks) Adjuvant Chemotherapy - Cycle length: 3 weeks (21D). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 2 Nov 2026.

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