A Study of Cadonilimab Combined With Chemotherapy in People With Gastric or Gastroesophageal Junction Cancer
1 de junio de 2026 actualizado por: 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
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
37
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Daniela Molena, MD
- Número de teléfono: 212-639-3870
- Correo electrónico: molenad@mskcc.org
Copia de seguridad de contactos de estudio
- Nombre: Yelena Janjigian, MD
- Número de teléfono: 646-888-4286
- Correo electrónico: janjigiy@mskcc.org
Ubicaciones de estudio
-
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New Jersey
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Basking Ridge, New Jersey, Estados Unidos, 07920
- Reclutamiento
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
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Contacto:
- Yelena Janjigian, MD
- Número de teléfono: 646-888-4286
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Middletown, New Jersey, Estados Unidos, 07748
- Reclutamiento
- Memorial Sloan Kettering Monmouth (Limited protocol activities)
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Contacto:
- Yelena Janjigian, MD
- Número de teléfono: 646-888-4286
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Montvale, New Jersey, Estados Unidos, 07645
- Reclutamiento
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)
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Contacto:
- Yelena Janjigian, MD
- Número de teléfono: 646-888-4286
-
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New York
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Commack, New York, Estados Unidos, 11725
- Reclutamiento
- Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
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Contacto:
- Yelena Janjigian, MD
- Número de teléfono: 646-888-4286
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Harrison, New York, Estados Unidos, 10604
- Reclutamiento
- Memorial Sloan Kettering Westchester (Limited protocol activities)
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Contacto:
- Yelena Janjigian, MD
- Número de teléfono: 646-888-4286
-
New York, New York, Estados Unidos, 10065
- Reclutamiento
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
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Contacto:
- Yelena Y Janjigian, MD
- Número de teléfono: 646-888-4286
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Uniondale, New York, Estados Unidos, 11553
- Reclutamiento
- Memorial Sloan Kettering Nassau (Limited protocol activities)
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Contacto:
- Yelena Janjigian, MD
- Número de teléfono: 646-888-4286
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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:
- Hemoglobin ≥9.0 g/dL
- Absolute neutrophil count ≥1.5 x 109/L
- Platelet count ≥100 x 109/L
- 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.
- ALT and AST ≤2.5 x ULN
- Albumin ≥2.8g/dL (albumin infusion is not allowed within 14 days before the start of treatment)
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:
- Interstitial lung disease (ILD), including history of ILD or non-infectious pneumonitis.
- Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of initiation of cadonilimab with the exception of prophylactic antibiotic treatment.
- 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.
- A condition or unresolved AE from a prior investigational drug that may obscure interpretation of toxicity determination or AEs.
- 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.
- Replacement therapy (e.g. insulin, levothyroxine) is not considered a form of systemic treatment.
- Participants with asthma who require intermittent use of bronchodilators, inhaled steroids, or local steroid injections not excluded.
- 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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Participants with HER2-negative gastric or GEJ adenocarcinoma
Participants will have locally advanced, resectable, HER2-negative gastric or GEJ adenocarcinoma
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Perioperative cadonilimab plus neoadjuvant chemotherapy
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Event-free survival (EFS) rata
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Yelena Janjigian, MD, Memorial Sloan Kettering Cancer Center
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
27 de mayo de 2026
Finalización primaria (Estimado)
27 de mayo de 2029
Finalización del estudio (Estimado)
27 de mayo de 2029
Fechas de registro del estudio
Enviado por primera vez
1 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
1 de junio de 2026
Publicado por primera vez (Actual)
5 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
1 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 26-102
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .