- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05130684
Neo-NTP-CRT for Locally Advanced ESCC (Neo-NTP-CRT)
Neoadjuvant Nivolumab Plus Paclitaxel/ Cisplatin- Chemo- Radiotherapy (Neo-NTP-CRT) Followed by Esophagectomy for Locally Advanced Esophageal Squamous Cell Carcinoma (ESCC)
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 2
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ta-Chen Huang, MD
- Número de teléfono: 71669 +886223123456
- Correo electrónico: e360215@gmail.com
Ubicaciones de estudio
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Taipei, Taiwán, 100
- Reclutamiento
- National Taiwan University Hospital
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Contacto:
- Ta-Chen Huang, MD
- Número de teléfono: 71669 +886223123456
- Correo electrónico: e360215@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Pathologically proven squamous cell carcinoma of the intrathoracic esophagus.
Locally advanced disease, which is defined by the TNM system of the American Joint Committee on Cancer (AJCC) Cancer Staging System (8th edition), fulfilling one of the following criteria as determined by endoscopic ultrasound, computed tomography, bronchoscopy and positron emission tomography:
- cT3/4a, N0, M0;
- cT1-3, N1-3, M0.
- Tumor length longitudinal ≤ 8cm and radial ≤ 5cm.
- The tumor must not extend more than 2cm into the stomach.
- No invasion of the tracheobronchial tree or presence of tracheoesophageal fistula.
- Age ≥ 20 and ≤ 75 years old.
- Performance status ECOG 0~1.
Adequate bone marrow reserves, defined as:
- white blood cells (WBC) ≥ 4,000/µl or neutrophil count (ANC) ≥ 2,000/µl;
- platelets ≥ 100,000/µl.
Adequate liver function reserves, defined as:
- hepatic transaminases ≤ 2.5 x upper limit of normal (ULN);
- serum total bilirubin ≤ 2.0 x upper limit of normal (ULN).
- Adequate renal function: Creatinine ≤1.5 x upper normal limit or estimated creatinine clearance ≥ 50 ml/min (estimated by Cockcroft-Gault formulation)
- Written informed consent.
- Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female subjects of childbearing potential must be willing to use an adequate method of contraception as outlined in Section - Contraception, for the course of the study through 120 days after the last dose of study medication.
Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
- Male subjects of childbearing potential must agree to use an adequate method of contraception as outlined in Section - Contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy.
Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Exclusion Criteria:
- Adenocarcinoma.
- Previous thoracic irradiation.
- Previous systemic chemotherapy
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- Synchronously diagnosed squamous cell carcinoma of aerodigestive way, other than esophageal cancer.
Prior malignancy, except for the following:
- adequately treated basal cell or squamous cell skin cancer;
- in-situ cervical cancer;
- a "cured" malignancy more than 5 years prior to enrollment.
- Significant co-morbid disease, which prohibits the conduction of chemotherapy, concurrent chemo- radiotherapy, or radical surgery, such as active systemic infection, symptomatic cardiac or pulmonary disease, or psychiatric disorders.
- Documented myocardial infarction within the 6 months preceding registration (pretreatment ECG evidence of infarct only will not exclude patients). Patients with a history of significant ventricular arrhythmia requiring medication. Patients with a history of 2nd or 3rd degree heart block.
- Pre-existing motor or sensory neurotoxicity greater than grade 1.
- Patients with prior allergic reactions to drug containing Cremophor, such as teniposide or cyclosporine.
- Weight loss > 15%.
- Dementia or altered mental status that would prohibit the understanding and completion of informed consent.
- Estimated life expectancy less than 3 months.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Has a known history of active TB (Bacillus Tuberculosis)
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Has known history of, or any evidence of active, non-infectious pneumonitis, interstitial lung disease or pulmonary fibrosis.
- Concurrent diverticulitis or symptomatic gastrointestinal ulcerative disease.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., anti-HCV reactive and HCV RNA [qualitative] are detected).
- Patients with a negative HBs antigen test but a positive test result for either HBs antibody or HBc antibody with a detectable level of HBV-DNA.
- Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
- Has received organ transplantation.
Plan de estudios
¿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: Neo-CRT
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adding nivolumab to conventional neoadjuvant CRT
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
change in treatment related death
Periodo de tiempo: 30 days
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no increase of treatment-related death within 30 days after esophagectomy
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30 days
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rate of completion of protocol treatment
Periodo de tiempo: 5 months
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successful completion of preoperative therapy and processing to surgery without any extended treatment-related delay, which is defined as > 19 weeks after the first dose of nivolumab (d-14) in neo-NTP-CRT (19 weeks include 15 weeks of protocol treatment plus 4 weeks of flexibility.).
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5 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Chih-Hung Hsu, MD PhD, National Taiwan University Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias por sitio
- Neoplasias Glandulares y Epiteliales
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades Gastrointestinales
- Neoplasias de Cabeza y Cuello
- Enfermedades esofágicas
- Neoplasias De Células Escamosas
- Neoplasias Esofágicas
- Carcinoma
- Carcinoma De Células Escamosas
- Carcinoma de células escamosas de esófago
- Mecanismos moleculares de acción farmacológica
- Agentes antineoplásicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Agentes antineoplásicos, fitogénicos
- Agentes antineoplásicos inmunológicos
- Inhibidores de puntos de control inmunitarios
- Paclitaxel
- Cisplatino
- Nivolumab
Otros números de identificación del estudio
- 202005115MIPB
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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. .
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