- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07662070
Emotional Distress and Pathologic Response in Locally Advanced Gastric/GEJ Adenocarcinoma
17 de junio de 2026 actualizado por: Ting Liu, West China Second University Hospital
A Prospective Observational Study of the Association Between Pretreatment Emotional Distress and Pathologic Response to Perioperative Immunotherapy in Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
This is a single-center, prospective observational cohort study designed to evaluate the association between pretreatment emotional distress and pathologic response to perioperative immunotherapy in patients with locally advanced gastric or gastroesophageal junction adenocarcinoma.
A total of 120 patients planned for neoadjuvant immunotherapy followed by curative surgery will be enrolled.
Emotional distress will be assessed using the PHQ-9 and GAD-7 before treatment initiation and at prespecified time points during treatment.
Participants will be classified into an emotional distress group or a non-emotional distress group according to predefined criteria.
The primary endpoint is major pathological response (MPR).
Secondary endpoints include pathological complete response (pCR), R0 resection rate, event-free survival (EFS), recurrence-free survival (RFS), and overall survival (OS).
Exploratory analyses will assess dynamic changes in emotional distress and their associations with peripheral stress markers, peripheral immune markers, and tumor immune microenvironment features.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Estimado)
120
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: Qing Li, PhD/MD
- Número de teléfono: +8618702848178
- Correo electrónico: liqing@scu.edu.cn
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
Método de muestreo
Muestra no probabilística
Población de estudio
Adults with histologically confirmed, resectable, locally advanced gastric or gastroesophageal junction adenocarcinoma who are planned to receive neoadjuvant/perioperative immunotherapy followed by curative-intent surgery at West China Hospital.
Eligible participants must have stage II-III disease without distant metastasis, an ECOG performance status of 0-1, no prior systemic antitumor treatment for the current tumor at baseline, and the ability to complete questionnaire assessments before and during treatment.
Descripción
Inclusion Criteria:
- Willing to participate in this study.
- Age >18 years; both sexes are eligible.
- Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
- Resectable locally advanced disease as assessed by imaging and/or multidisciplinary team evaluation, generally corresponding to AJCC 8th edition stage II-III disease, including cT3-4a with any N category or any T with node-positive disease, without distant metastasis.
- Planned to receive neoadjuvant therapy followed by curative-intent surgery.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- No prior systemic antitumor treatment for the current tumor at baseline.
- Able to understand and complete questionnaire assessments.
- Able and willing to provide written informed consent.
Exclusion Criteria:
- Presence of distant metastasis, peritoneal metastasis, or loss of curative treatment opportunity as determined by clinical evaluation.
- Prior neoadjuvant chemotherapy, immunotherapy, radiotherapy, or other systemic antitumor treatment for the current tumor.
- Severe cognitive impairment, acute psychiatric disorder, or any condition that precludes completion of questionnaire assessments.
- Current treatment with antidepressants, anxiolytics, or other psychotropic medications with any of the following within 4 weeks before baseline assessment: initiation, discontinuation, change in medication type, dose adjustment of 50% or more, or addition of a second or more psychotropic medication.
- Any other condition judged by the investigator to make the participant unsuitable for enrollment.
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
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Pretreatment Emotional Distress
Participants with pretreatment emotional distress, defined as a PHQ-9 score of 5 or higher and/or a GAD-7 score of 5 or higher before initiation of perioperative immunotherapy.
These participants will receive standard perioperative immunotherapy and routine clinical care according to the treating physician's plan.
This observational study will compare pathologic response and clinical outcomes between participants with and without pretreatment emotional distress.
|
No aplicable- estudio observacional
|
|
No Pretreatment Emotional Distress
Participants without pretreatment emotional distress, defined as a PHQ-9 score lower than 5 and a GAD-7 score lower than 5 before initiation of perioperative immunotherapy.
These participants will receive standard perioperative immunotherapy and routine clinical care according to the treating physician's plan.
This observational study will compare pathologic response and clinical outcomes between participants with and without pretreatment emotional distress.
|
No aplicable- estudio observacional
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
major pathological response
Periodo de tiempo: Assessed on surgical pathology after completion of neoadjuvant treatment and curative resection, approximately 6 to 12 weeks after treatment initiation
|
Defined as 10% or less residual viable tumor cells in the resected primary tumor specimen after perioperative immunotherapy
|
Assessed on surgical pathology after completion of neoadjuvant treatment and curative resection, approximately 6 to 12 weeks after treatment initiation
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pathological Complete Response (pCR)
Periodo de tiempo: Assessed on surgical pathology at the time of curative resection, approximately 6 to 12 weeks after initiation of perioperative immunotherapy
|
Pathological complete response is defined as the absence of residual viable tumor cells in the resected primary tumor and all examined regional lymph nodes after completion of neoadjuvant immunotherapy and curative surgery.
|
Assessed on surgical pathology at the time of curative resection, approximately 6 to 12 weeks after initiation of perioperative immunotherapy
|
|
Event-Free Survival (EFS)
Periodo de tiempo: From enrollment up to 24 months
|
Event-free survival is defined as the time from study enrollment to the first occurrence of any of the following events: disease progression during neoadjuvant treatment, failure to undergo curative surgery, postoperative recurrence, or death from any cause.
|
From enrollment up to 24 months
|
|
Overall Survival (OS)
Periodo de tiempo: From enrollment up to 36 months
|
Overall survival is defined as the time from study enrollment to death from any cause.
|
From enrollment up to 36 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Estimado)
26 de junio de 2026
Finalización primaria (Estimado)
1 de julio de 2028
Finalización del estudio (Estimado)
31 de diciembre de 2028
Fechas de registro del estudio
Enviado por primera vez
17 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de junio de 2026
Publicado por primera vez (Actual)
23 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
23 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
17 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- ED-GCGEJ
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
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. .