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A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.

4. november 2026 oppdatert av: AstraZeneca

A Randomized, Double-blind, Placebo-controlled Study of Neoadjuvant-Adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable Gastric and Gastroesophageal Junction Cancer (GC/GEJC) (MATTERHORN-CN).

This study aims to assess the efficacy and safety of neoadjuvant adjuvant treatment with durvalumab in combination with FLOT compared to placebo in combination with FLOT in Chinese patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC) (MATTERHORN-CN).

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Informed by the favorable benefit-risk profile demonstrated by the global MATTERHORN study, the current study is designed to assess the efficacy and safety of neoadjuvant-adjuvant durvalumab in combination with FLOT chemotherapy followed by adjuvant durvalumab monotherapy (Arm A), compared with neoadjuvant-adjuvant placebo in combination with FLOT chemotherapy followed by adjuvant placebo monotherapy (Arm B) in Chinese participants with resectable GC/GEJC. Approximately 140 participants will be randomized to either Arm A or Arm B.

Studietype

Intervensjonell

Registrering (Antatt)

140

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
      • Beijing, Kina, 102218
        • Har ikke rekruttert ennå
        • Research Site
      • Beijing, Kina, 100050
        • Har ikke rekruttert ennå
        • Research Site
      • Beijing, Kina, 100142
        • Rekruttering
        • Research Site
      • Beijing, Kina, 100730
        • Har ikke rekruttert ennå
        • Research Site
      • Beijing, Kina, 102206
        • Har ikke rekruttert ennå
        • Research Site
      • Bengbu, Kina, 233004
        • Har ikke rekruttert ennå
        • Research Site
      • Changchun, Kina, 130021
        • Har ikke rekruttert ennå
        • Research Site
      • Changchun, Kina, 130033
        • Rekruttering
        • Research Site
      • Changsha, Kina, 410008
        • Har ikke rekruttert ennå
        • Research Site
      • Changzhi, Kina, 046000
        • Har ikke rekruttert ennå
        • Research Site
      • Chengdu, Kina, 610041
        • Rekruttering
        • Research Site
      • Chengdu, Kina, 610041
        • Har ikke rekruttert ennå
        • Research Site
      • Chongqing, Kina, 400042
        • Har ikke rekruttert ennå
        • Research Site
      • Fuzhou, Kina, 350001
        • Har ikke rekruttert ennå
        • Research Site
      • Guangzhou, Kina, 510080
        • Har ikke rekruttert ennå
        • Research Site
      • Guangzhou, Kina, 510120
        • Har ikke rekruttert ennå
        • Research Site
      • Guangzhou, Kina, 510655
        • Har ikke rekruttert ennå
        • Research Site
      • Hangzhou, Kina, 310014
        • Rekruttering
        • Research Site
      • Hangzhou, Kina, 310016
        • Har ikke rekruttert ennå
        • Research Site
      • Hohhot, Kina, 010020
        • Har ikke rekruttert ennå
        • Research Site
      • Jinan, Kina, 250021
        • Har ikke rekruttert ennå
        • Research Site
      • Jinan, Kina, 250014
        • Rekruttering
        • Research Site
      • Kunming, Kina, 650118
        • Har ikke rekruttert ennå
        • Research Site
      • Lanzhou, Kina, 730000
        • Rekruttering
        • Research Site
      • Lanzhou, Kina, 730030
        • Har ikke rekruttert ennå
        • Research Site
      • Meizhou, Kina, 514031
        • Rekruttering
        • Research Site
      • Nanchang, Kina, 330006
        • Har ikke rekruttert ennå
        • Research Site
      • Nanjing, Kina, 210029
        • Har ikke rekruttert ennå
        • Research Site
      • Nanjing, Kina, 210009
        • Har ikke rekruttert ennå
        • Research Site
      • Nanning, Kina, 530021
        • Har ikke rekruttert ennå
        • Research Site
      • Qingdao, Kina, 266003
        • Rekruttering
        • Research Site
      • Shanghai, Kina, 200032
        • Har ikke rekruttert ennå
        • Research Site
      • Shanghai, Kina, 201210
        • Har ikke rekruttert ennå
        • Research Site
      • Shanghai, Kina, 200031
        • Har ikke rekruttert ennå
        • Research Site
      • Shaoguan, Kina, 512027
        • Rekruttering
        • Research Site
      • Shenyang, Kina, 110042
        • Har ikke rekruttert ennå
        • Research Site
      • Suining Shi, Kina, 629000
        • Rekruttering
        • Research Site
      • Taiyuan, Kina, 030000
        • Har ikke rekruttert ennå
        • Research Site
      • Wuhan, Kina, 430030
        • Har ikke rekruttert ennå
        • Research Site
      • Xi'an, Kina, 710068
        • Rekruttering
        • Research Site
      • Zhengzhou, Kina, 450000
        • Har ikke rekruttert ennå
        • Research Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • 1. Capable of giving signed informed consent. 2. Male and/or Female, Age ≥ 18 years at the time of screening. 3. Histologically documented gastric or gastroesophageal junction adenocarcinoma with resectable disease, GEJC includes Siewert* type 2 and 3 tumour and Siewert* type 1 tumour.

    1. Per the judgment of the Investigator, participants must be medically fit for treatment with neoadjuvant FLOT therapy prior to radical surgery.

    2. At screening, complete surgical resection of the primary GC/GEJC must be deemed achievable, as assessed by a multidisciplinary evaluation, which must include a board certified GI surgeon.

    3. No prior anti-cancer therapy (eg, chemotherapy, radiation therapy, or chemoradiation therapy) for the current malignancy.

      4. ECOG PS of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline at screening and prior to randomization.

      5. Adequate organ and marrow function as defined below:

    1. Haemoglobin ≥ 9.0 g/dL
    2. Absolute neutrophil count ≥ 1.5 × 109/L
    3. Platelet count ≥ 100 × 109/L
    4. Serum bilirubin ≤ 1.5 ×ULN. This will not apply to participants with confirmed Gilbert's syndrome, who will be allowed in consultation with their physician.
    5. ALT and AST ≤ 2.5 × ULN
    6. Measured CL > 50 mL/min or Calculated CL > 50 mL/min as determined by Cockcroft-Gault (using actual body weight) 6. Must have a life expectancy of at least 24 weeks. 7. Body weight > 30 kg at enrolment and randomization. 8. Meeting tumour sample requirements (at screening) to confirm PD-L1 status.

Exclusion Criteria:

  • -1. Participants with peritoneal dissemination (including tumour cells in peritoneal fluid) or distant metastasis.

    2. Participants with adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumour.

    3. History of allogeneic organ transplantation. 4. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], systemic lupus erythematosus, sarcoidosis, granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc), autoimmune pneumonitis, and autoimmune myocarditis.

    5. Uncontrolled intercurrent illness that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.

    6. History of another primary malignancy except for

    (a) Malignancy treated with curative intent and with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence (b) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease (c) Adequately treated carcinoma in situ without evidence of disease 7. History of active primary immunodeficiency. 8. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice) and HIV verified by positive HIV-1 or HIV-2 antibodies.

    9. Mean QTc ≥ 470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart).

    10. Known allergy or hypersensitivity to any of the study interventions or any of the study intervention excipients.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Arm A

Durvalumab +FLOT followed by durvalumab
Legemiddel: FLOT Chemotherapy

A combination treatment made up of flurouroacil + leucovorin + oxaliplatin + docetaxel

Legemiddel: Durvalumab

Human monoclonal antibody
Placebo komparator: Arm B

Placebo +FLOT followed by Placebo
Legemiddel: FLOT Chemotherapy

A combination treatment made up of flurouroacil + leucovorin + oxaliplatin + docetaxel

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
To compare Arm A relative to Arm B on pCR rate
Tidsramme: Up to 24 months after the last participant is randomized

pCR rate is defined as the proportion of participants who have no residual viable tumour in the resected specimens and as determined by central pathology review.
Up to 24 months after the last participant is randomized

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
To compare Arm A relative to Arm B on event-free survival at 24 months (EFS24)
Tidsramme: Up to 24 months after the last participant is randomized

EFS24 is the proportion of participants alive and event free 24 months after randomization, according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 per Investigator assessment and/or locally by pathology testing.
Up to 24 months after the last participant is randomized
To compare Arm A relative to Arm B on overall survival (OS)
Tidsramme: Up to 24 months after the last participant is randomized

Overall survival is length of time from randomization until the date of death due to any cause.
Up to 24 months after the last participant is randomized
To compare Arm A relative to Arm B on event-free survival (EFS)
Tidsramme: Up to 24 months after the last participant is randomized

EFS is defined as the time from randomization to the following, according to RECIST 1.1 per Investigator assessment and/or locally by pathology testing:

  1. Progression that precludes surgery or requires non-protocol therapy,
  2. Local or distant recurrence or progression of disease, or 3) Death due to any cause.
Up to 24 months after the last participant is randomized
To compare Arm A relative to Arm B on the rate of complete resection (R0)
Tidsramme: Up to 24 months after the last participant is randomized

R0 resection (complete resection) rate is the proportion of participants who have a confirmed complete resection as assessed by pathology review.
Up to 24 months after the last participant is randomized
To compare Arm A relative to Arm B on metastasis-free survival (MFS) and disease-specific survival (DSS)
Tidsramme: Up to 24 months after the last participant is randomized

MFS is the time from randomization until the development of metastasis using RECIST 1.1 or death due to any cause.

• DSS is the time from randomization untildeath due to GC/GEJC.
Up to 24 months after the last participant is randomized
To compare Arm A relative to Arm B on disease-free survival (DFS) in participants who undergo R0 resection surgery
Tidsramme: Up to 24 months after the last participant is randomized

DFS is defined as the time from first post-surgery scan until disease recurrence, using RECIST 1.1, or death due to any cause.
Up to 24 months after the last participant is randomized

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
To assess the safety and tolerability of Arm A as compared to Arm B in participants with GC/GEJC
Tidsramme: Up to 24 months after the last participant is randomized

Safety and tolerability will be evaluated in terms of adverse events (AEs)
Up to 24 months after the last participant is randomized

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

AstraZeneca

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

9. oktober 2026

Primær fullføring (Antatt)

1. november 2029

Studiet fullført (Antatt)

1. november 2029

Datoer for studieregistrering

Først innsendt

15. september 2026

Først innsendt som oppfylte QC-kriteriene

9. oktober 2026

Først lagt ut (Faktiske)

16. oktober 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • D907JC00001

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

IPD will be sharedQualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. upon certain conditions.

IPD-delingstidsramme

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Tilgangskriterier for IPD-deling

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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