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A Study of Cadonilimab Combined With Chemotherapy in People With Gastric or Gastroesophageal Junction Cancer

1 juni 2026 bijgewerkt door: Memorial Sloan Kettering Cancer Center

A Phase 2, Single-arm Study of Cadonilimab and FLOT Chemotherapy in Patients With Locally Advanced, Resectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

The purpose of this study is to find out whether adding cadonilimab to the usual chemotherapy approach is an effective and safe treatment for participants with locally advanced/resectable gastric cancer or gastroesophageal junction (GEJ) cancer

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

37

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Verenigde Staten
    • New Jersey
      • Basking Ridge, New Jersey, Verenigde Staten, 07920
        • Werving
        • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
        • Contact:
          • Yelena Janjigian, MD
          • Telefoonnummer: 646-888-4286
      • Middletown, New Jersey, Verenigde Staten, 07748
        • Werving
        • Memorial Sloan Kettering Monmouth (Limited protocol activities)
        • Contact:
          • Yelena Janjigian, MD
          • Telefoonnummer: 646-888-4286
      • Montvale, New Jersey, Verenigde Staten, 07645
        • Werving
        • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
        • Contact:
          • Yelena Janjigian, MD
          • Telefoonnummer: 646-888-4286
    • New York
      • Commack, New York, Verenigde Staten, 11725
        • Werving
        • Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
        • Contact:
          • Yelena Janjigian, MD
          • Telefoonnummer: 646-888-4286
      • Harrison, New York, Verenigde Staten, 10604
        • Werving
        • Memorial Sloan Kettering Westchester (Limited protocol activities)
        • Contact:
          • Yelena Janjigian, MD
          • Telefoonnummer: 646-888-4286
      • New York, New York, Verenigde Staten, 10065
        • Werving
        • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
        • Contact:
          • Yelena Y Janjigian, MD
          • Telefoonnummer: 646-888-4286
      • Uniondale, New York, Verenigde Staten, 11553
        • Werving
        • Memorial Sloan Kettering Nassau (Limited protocol activities)
        • Contact:
          • Yelena Janjigian, MD
          • Telefoonnummer: 646-888-4286

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • Capable of providing signed informed consent.
  • Age ≥18 years at time of informed consent.
  • ECOG performance status (PS) of 0 or 1 at enrollment.
  • Pathologically confirmed gastric or GEJ adenocarcinoma with T1 N+ M0 or T2-4 N0-3 M0 (per AJCC 8th edition) resectable disease deemed eligible for radical surgery. A diagnostic laparoscopy is strongly recommended to confirm M0 status.
  • HER2-negative tumor (IHC 0, 1+, or IHC 2+ and FISH non-amplified).

  • Adequate organ and marrow function as defined below:

    1. Hemoglobin ≥9.0 g/dL
    2. Absolute neutrophil count ≥1.5 x 109/L
    3. Platelet count ≥100 x 109/L
    4. Serum bilirubin ≤1.5 x upper limit of normal (ULN). Patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may be enrolled.
    5. ALT and AST ≤2.5 x ULN
    6. Albumin ≥2.8g/dL (albumin infusion is not allowed within 14 days before the start of treatment)

    7. Measured creatinine clearance >50 mL/min as determined by Cockcroft-Gault using actual body weight 7. Willing and able to undergo pre-treatment (during screening) and on-treatment tumor biopsies.

      8. Women of childbearing potential (as defined in Section 13.3) must have a negative serum pregnancy test within 72 hours prior to the first dose and agree to take effective contraception measures during the study drug administration and within 9 months after the last dose.

      9. Male patients with female partners of childbearing potential (as defined in Section 13.3) must agree to take effective contraception measures during the study drug administration and within 6 months after the last dose.

      Exclusion Criteria:

  • Histologies other than adenocarcinoma, including squamous/adenosquamous cell carcinoma, neuroendocrine, or GI stromal tumor.
  • HER2-positive tumor (IHC 2+ and FISH-amplified, or IHC 3+).
  • Prior anticancer treatment for the disease under study (chemotherapy, radiation therapy, chemoradiation, approved or investigational therapy) prior to initiation of study treatment.
  • Prior receipt of an anti-PD1 or anti-CTLA4 monoclonal antibody, including for prior non-gastric malignancy.

  • Underlying medical conditions that, in the Investigator's opinion, make the administration of cadonilimab hazardous, including but not limited to:

    1. Interstitial lung disease (ILD), including history of ILD or non-infectious pneumonitis.
    2. Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of initiation of cadonilimab with the exception of prophylactic antibiotic treatment.
    3. Clinically significant cardiovascular disease, such as New York Heart Association Class II or greater cardiac disease or cerebrovascular accident within 3 months prior to initiation of study treatment, myocardial infarction within 6 months prior to initiation of study treatment, or unstable arrhythmia.
    4. A condition or unresolved AE from a prior investigational drug that may obscure interpretation of toxicity determination or AEs.
    5. History of prior solid-organ transplant, including allogeneic bone marrow transplant.
  • Concurrent chronic medical condition requiring the use of supraphysiologic doses of corticosteroids (>10 mg/day of oral prednisone or equivalent) or immunosuppressive medications (absorbable topical corticosteroids not excluded).

  • Any active autoimmune disease or documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (i.e. with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma or atopy.

    1. Replacement therapy (e.g. insulin, levothyroxine) is not considered a form of systemic treatment.
    2. Participants with asthma who require intermittent use of bronchodilators, inhaled steroids, or local steroid injections not excluded.
    3. Participants with hypothyroidism stable on hormone replacement or Sjogren's syndrome not excluded.
  • Known hypersensitivity to any excipient contained in the formulations of study interventions.
  • Prior active malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer(s), superficial bladder cancer, or carcinoma in-situ of the cervix, breast, or prostate cancer. Other cases of prior malignanices may be allowed after discussion with the Principal Investigator.
  • Known HIV infection with detectable viral load. Patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  • Known acute hepatitis B or chronic hepatitis B infection with active untreated disease. For patients with evidence of chronic infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
  • Known hepatitis C infection with detectable viral RNA. Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load.
  • Receipt of a live attenuated vaccine within 30 days of study treatment initiation.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Participants with HER2-negative gastric or GEJ adenocarcinoma
Participants will have locally advanced, resectable, HER2-negative gastric or GEJ adenocarcinoma
Geneesmiddel: Cadonilimab
Perioperative cadonilimab plus neoadjuvant chemotherapy

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Event-free survival (EFS) rata
Tijdsspanne: 18 months
To determine the 18-month event-free survival (EFS) rate in patients with locally advanced, resectable, HER2-negative gastric or GEJ adenocarcinoma treated with perioperative cadonilimab and FLOT chemotherapy
18 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Memorial Sloan Kettering Cancer Center

Onderzoekers

  • Hoofdonderzoeker: Yelena Janjigian, MD, Memorial Sloan Kettering Cancer Center

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

27 mei 2026

Primaire voltooiing (Geschat)

27 mei 2029

Studie voltooiing (Geschat)

27 mei 2029

Studieregistratiedata

Eerst ingediend

1 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

1 juni 2026

Eerst geplaatst (Werkelijk)

5 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

1 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 26-102

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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