- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07704645
The Clinical Study of Adalimumab Combined With Other Anti-tumor Therapy as a Treatment for Resectable Non-small Cell Lung Cancer
A Phase II Clinical Study of Adebelizumab Combined With Other Anti-tumor Treatments as a Perioperative Treatment for Resectable Non-small Cell Lung Cancer
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yanhua Huang
- Número de teléfono: 0518-82342973
- Correo electrónico: Yanhua.Huang@hengrui.com
Ubicaciones de estudio
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200000
- Shanghai Pulmonary Hospital
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Investigador principal:
- Chang Chen
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- voluntarily participate in this clinical study, understand the research procedure and be able to sign the informed consent in writing ;
- At the time of signing the informed consent form, the age is 18-70 years old ( including both ends ), both men and women can.
The ECOG score was 0 or 1. 4. Patients with histopathologically or cytologically confirmed Stage II, IIIA, or select Stage IIIB (AJCC 9th edition) non-small cell lung cancer who are candidates for curative-intent R0 surgical resection.
5.Combined genetic requirements : non-squamous cell carcinoma subjects must undergo EGFR gene detection and ALK gene and or immunohistochemical detection.
6.Can provide tumor tissue specimens, which can be archived or freshly obtained specimens for biomarker detection.
7.According to the RECIST v1.1 standard, subjects must have measurable target lesions examined by CT or MRI. Tumor imaging evaluation was performed within 28 days before the first administration.
8.There is sufficient hematology and organ function, as defined by the results of laboratory tests, to be completed within 7 days prior to the first dose of treatment : 9.Women of childbearing age must have a serum pregnancy test within 7 days before the first administration, and the result is negative. Women of childbearing age and men whose partners are women of childbearing age must agree to use an efficient method of contraception from the date of signing the informed consent to at least 26 weeks ( female subjects ) or 14 weeks ( male subjects ) after the last administration.
Exclusion Criteria:
- Small cell lung cancer ( SCLC ) and NSCLC mixed tumors confirmed by histology or cytology contain non-NSCLC pathological types such as small cell components.
3.Have previously received systematic anti-tumor therapy for non-small cell lung cancer other than this study ( including clinical research drugs ) ; 4.Participants who had received or planned to receive local treatment such as chest radiotherapy or ablation ;
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: PART A
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Adebrelimab Injection combined with SHR-1826 Injection combined with SHR-8068 Injection
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Experimental: PART B
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Adebrelimab Injection combined with HRS-7058 Capsule
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Pathological complete response (pCR) rate: pCR is defined as the absence of any residual tumor at the time of surgical resection.
Periodo de tiempo: All results are expected to be obtained in the last participant three months after surgery.
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All results are expected to be obtained in the last participant three months after surgery.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Event-free survival (EFS)
Periodo de tiempo: In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant
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EFS is defined as the time from the first dose to any of the following events: any progression of disease precluding surgery; progression or recurrent disease based on investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after surgery; or death from any cause.
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In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant
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Disease-free survival (DFS) as assessed byinvestigator
Periodo de tiempo: In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant
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DFS is defined as the time from firste dose to any recurrence (local, locoregional, regional or distant), occurrence of new primary NSCLC, or death due to any cause, whichever occurs first.
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In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant
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Objective response rate (ORR): assessed by the investigator
Periodo de tiempo: In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant
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In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant
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Overall Survival (OS)
Periodo de tiempo: In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant
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OS is defined as the time from first dose to death due to any cause.
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In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Otros números de identificación del estudio
- SHR-1316-207
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.
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. .