Eficacia y seguridad de Adebrelimab combinada con quimiorradioterapia en pacientes con carcinoma de células esofágicas esofágicas recurrentes no resecables o postoperatorias o postoperatorias postoperatorias
Un estudio clínico de fase II sobre la eficacia y la seguridad de Adebrelimab combinado con quimiorradioterapia en pacientes con carcinoma de células escamosas esofágicas recurrentes no resecables o postoperatorias postoperatorias
This study was a multi-center, single-arm, open-label phase II clinical trial. Thirty patients with unresectable locally advanced or postoperative recurrent esophageal squamous cell carcinoma were treated with concurrent chemoradiotherapy combined with immunotherapy. The radiotherapy regimen was intensity-modulated radiotherapy with PGTV at 50-50.4 Gy/25-28 fractions, 1.8-2 Gy per fraction, five times a week. The chemotherapy regimen was paclitaxel 50 mg/m2 and cisplatin 25 mg/m2 intravenous infusion on day 1, once a week for five times. The immunotherapy was with adebutilimab at 1200 mg on day 1, every three weeks for three times. One week before radiotherapy, gastroscopy, chest CT or PET-CT images were taken as the baseline standard. Based on the results of gastroscopy, chest CT or PET-CT before and after treatment, the number of patients with complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) in the two groups was observed. The objective response rate (ORR) was calculated as CR + PR, and the disease control rate (DCR) was calculated as CR + PR + SD. The progression-free survival (PFS), overall survival (OS), 1-year and 2-year survival rates and adverse reactions were also statistically analyzed.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Guangdong
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Guangzhou, Guangdong, Porcelana
- Nanfang Hospital, Southern Medical University
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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:
- Age 18-75 years old, gender unlimited
- Esophageal squamous cell carcinoma confirmed by histology and unresectable locally advanced or postoperative recurrence
- According to the solid tumor efficacy evaluation criteria (RECIST1.1), there is at least one measurable lesion; And the lesion had not received prior radiotherapy
- ECOG: 0~1
- Expected survival ≥12 weeks 6. Laboratory examination: neutrophils ≥1.5 x 109/L, platelets ≥100 x 109/L; Hemoglobin ≥ 9g/L; Albumin ≥ 2.8g/dL; Bilirubin ≤1.5 times ULN, ALT and AST≤2.5 times ULN
7: Subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up 8: Tissue samples should be provided for biomarker analysis such as (PD-L1). Newly acquired tissues are preferred, and 15 5-6um thick paraffin sections can not be provided for archiving by the recent organizer
Exclusion Criteria:
- Other malignant tumors have been diagnosed within the previous 5 years
- There is distant organ metastasis (according to AJCC stage, supraclavicular lymph node metastasis is M1, which should be excluded)
- Lesions invading the trachea or large blood vessels, or investigators judge that there is a high risk of esophageal/tracheal fistula or bleeding
- Have any history of active autoimmune disease or autoimmune disease
- Have clinical symptoms or diseases of the heart that are not under control
- Active infection or fever (except definite tumor fever)
- History or evidence of interstitial lung disease or active non-infectious pneumonia
- Patients with immune dysfunction and active hepatitis
- Those who have previously received PD-1 or PD-L1 antibody therapy
- Allergic to any drug in this protocol
- Patients receiving immunosuppressive drugs or corticosteroids >10mg/ day of prednisone therapeutic dose within 14 days prior to enrollment
- Patients who had received radiotherapy, chemotherapy, targeted therapy, or immunotherapy within 4 weeks prior to enrollment
- Pregnant or lactating women
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 |
|---|---|
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Experimental: Adebrelimab combinado con quimiorradioterapia
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Concurrent Chemoradiotherapy combined with Immunotherapy，including： Radiotherapy: intensity modulated radiotherapy, PGTV 50-50.4Gy/25-28F, 1.8-2Gy/F, 5 times a week; Chemotherapy: paclitaxel 50mg/ m2 + cisplatin 25mg/ m2, intravenous infusion of day1, once a week, a total of 5 times; Adebrelimab: 1200 mg day1, Q3W, 3 times. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Objective response rate at 3 months after radiotherapy (ORR)
Periodo de tiempo: Three months after radiation
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ORR includes Complete Response (CR) and Partial Response (PR) according to accepted response evaluation criteria (such as solid tumor RECIST version 1.1), (1) Complete response (CR) : Except for nodular disease, all target lesions disappeared completely. All target nodules must be reduced to normal size (short axis < 10 mm). All target lesions must be evaluated. (2) Partial response (PR) : Total diameter of all measurable target lesions is ≥ 30% below baseline. The short diameter was used for the sum of the target nodules, while the longest diameter was used for the sum of all other target lesions. All target lesions must be evaluated. |
Three months after radiation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Supervivencia general
Periodo de tiempo: Desde la fecha de inicio del tratamiento (o diagnóstico) hasta la fecha de muerte por cualquier causa, evaluada hasta 120 meses
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Desde la fecha de inicio del tratamiento (o diagnóstico) hasta la fecha de muerte por cualquier causa, evaluada hasta 120 meses
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Supervivencia libre de progresión
Periodo de tiempo: El tiempo desde el comienzo del tratamiento hasta la progresión tumoral o la muerte debido a cualquier causa, evaluada hasta 120 meses
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El tiempo desde el comienzo del tratamiento hasta la progresión tumoral o la muerte debido a cualquier causa, evaluada hasta 120 meses
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Clinical complete response rate
Periodo de tiempo: "Monitored throughout the treatment period and during follow-up, an average of 2 years"
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Except for nodular disease, all target lesions disappeared completely. All target nodules must be reduced to normal size (short axis < 10 mm). All target lesions must be evaluated |
"Monitored throughout the treatment period and during follow-up, an average of 2 years"
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Quality of life scores of cancer patients
Periodo de tiempo: "Monitored throughout the treatment period and during follow-up, an average of 2 years
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Assess the patient's physical function, psychological state, social function, symptom burden, and overall health status through telephone follow-ups, return visits for review, and other methods .The measurement tool is SF-36 Quality of Life Assessment Scale |
"Monitored throughout the treatment period and during follow-up, an average of 2 years
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
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
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Neoplasias por tipo histológico
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Neoplasias de Cabeza y Cuello
- Neoplasias Glandulares y Epiteliales
- Enfermedades esofágicas
- Carcinoma
- Neoplasias De Células Escamosas
- Carcinoma De Células Escamosas
- Neoplasias Esofágicas
- Carcinoma de células escamosas de esófago
Otros números de identificación del estudio
- NFEC-2024-242
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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