Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

4 november 2026 uppdaterad 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).

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

140

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Arm A

Durvalumab +FLOT followed by durvalumab
Läkemedel: FLOT Chemotherapy

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

Läkemedel: Durvalumab

Human monoclonal antibody
Placebo-jämförare: Arm B

Placebo +FLOT followed by Placebo
Läkemedel: FLOT Chemotherapy

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
To compare Arm A relative to Arm B on pCR rate
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
To compare Arm A relative to Arm B on event-free survival at 24 months (EFS24)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
To assess the safety and tolerability of Arm A as compared to Arm B in participants with GC/GEJC
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

AstraZeneca

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

9 oktober 2026

Primärt slutförande (Beräknad)

1 november 2029

Avslutad studie (Beräknad)

1 november 2029

Studieregistreringsdatum

Först inskickad

15 september 2026

Först inskickad som uppfyllde QC-kriterierna

9 oktober 2026

Första postat (Faktisk)

16 oktober 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • D907JC00001

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

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.

Kriterier för IPD Sharing Access

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-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera