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- Ensayo clínico NCT07429318
Análisis de Eficacia y Supervivencia del Tratamiento Perioperatorio del Cáncer Gástrico Localmente Avanzado o de la Unión Gastroesofágica (GC/GEJC)
Análisis de Eficacia y Pronóstico de Supervivencia del Tratamiento Perioperatorio del Adenocarcinoma Gástrico Localmente Avanzado o de la Unión Gastroesofágica
This study is a single-center, retrospective cohort study. The purpose is to evaluate different perioperative treatment options on the efficacy and survival prognosis of locally advanced GC/GEJC, clarify whether the tumor regression grade can influence survival of patients using neoadjuvant therapy. Moreover, we aim to explore the clinical and pathological characteristics that will affect the long-term survival benefit of patients who underwent perioperative treatment.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100021
- Cancer Hodpital, Chinese Academy of Medical Sciences and Peking Union Medical College
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
patients who had locally advanced GC/GEJC
Descripción
Inclusion Criteria:
- (1) Pathologically diagnosed as gastric adenocarcinoma or esophageal-gastric junction adenocarcinoma, and has not received any anti-tumor treatment before (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.)
- (2) cT3-4N+M0 (according to AJCC version 8 stage) confirmed as resectable by CT or MRI.
- (3) Patients who underwent adjuvant therapy before surgery.
- (4) After neoadjuvant therapy , radical resection was performed at the Cancer Hospital of the Chinese Academy of Medical Sciences.
- (5) Patients who have complete clinical, pathological and imaging data.
Exclusion Criteria:
- (1) It is known that peritoneal metastasis or peritoneal irrigation solution cytology is positive (CY1P0) or there is distant metastasis (according to the 8th edition of AJCC).
- (2) There are unresectable factors, including irresectable tumor causes or surgical contraindications that are irresectable or refuse surgery.
- (3) Those who have suffered from other malignant tumors within 5 years or at the same time, except for cured skin basal cell carcinoma and cervical cancer in situ and breast cancer in situ.
- (4) Those who have had radiotherapy, interventional treatment and other local therapists before surgery.
- (5) Patients whose key diagnosis and treatment information records were missing.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: RETROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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chemotherapy
patients who only used chemotherapy during neoadjuvant treatment |
Patients who only used chemotherapy during neodajuvant treatment period
Otros nombres:
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immunochemotherapy
patients who used immunotherapy combined with chemotherapy during neoadjuvant treatment |
Patients who used immunotherapy combined with chemotherapy during neodajuvant treatment period
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
OS
Periodo de tiempo: From the start date of cycle 1 (each cycle is 14 days or 21 days) neoadjuvant therapy until the date of first documented death from any cause, assessed up to 100 months.
|
overall survival |
From the start date of cycle 1 (each cycle is 14 days or 21 days) neoadjuvant therapy until the date of first documented death from any cause, assessed up to 100 months.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
EFS
Periodo de tiempo: From the start date of cycle 1 (each cycle is 14 days or 21 days) neoadjuvant therapy until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 100 months.
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event free survival |
From the start date of cycle 1 (each cycle is 14 days or 21 days) neoadjuvant therapy until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 100 months.
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DFS
Periodo de tiempo: From the start date of cycle 1 (each cycle is 14 days or 21 days) adjuvant therapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
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disease free survival |
From the start date of cycle 1 (each cycle is 14 days or 21 days) adjuvant therapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
|
Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Estimado)
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
Otros números de identificación del estudio
- NCC5964
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.
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