- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03776604
PEG-rhG-CSF in Elderly Patients With Small Cell Lung Cancer Receiving Chemotherapy
Multi-center, Open, One-arm Clinical Study Evaluating the Efficacy and Safety of Jinyouli (PEGylated Recombinant Human Granulocyte Stimulating Factor, PEG-rhG-CSF) in Preventing Neutropenia After Chemotherapy in Elderly Patients With Small Cell Lung Cancer
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jun Zhao, PhD
- Número de teléfono: 86-010-88196456
- Correo electrónico: ohjerry@163.com
Copia de seguridad de contactos de estudio
- Nombre: Hanxiao Chen
- Número de teléfono: 18810526948
- Correo electrónico: Hanxiao0628@163.com
Ubicaciones de estudio
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Beijing
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Beijing, Beijing, Porcelana, 100142
- Reclutamiento
- Bejing Cancer Hospital
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Contacto:
- Jun Zhao, PhD
- Número de teléfono: 86-010-88196456
- Correo electrónico: ohjerry@163.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:
- Age ≥ 70 years old, gender is not limited;
- Small cell lung cancer patients diagnosed by histopathology or cytology;
- ECOG = 0-1;
- The estimated survival period is more than 3 months;
- No obvious signs of hematological disease, defined as Hb≥90g/dL, WBC≥4.0×10^9/L, ANC≥2×10^9/L, PLT≥100×10^9/L before enrollment. And no bleeding tendency;
- No obvious abnormalities were observed in the electrocardiogram examination;
- Liver function tests ALT, AST, TBIL indicators are within 2.5 times the upper limit of normal values. If due to liver metastasis, the above indicators should be within 5 times of the upper limit of normal. If LDH is elevated due to non-tumor causes, LDH should be ≤ 2.5 times the upper limit of normal; if LDH is elevated due to tumor, it can be enrolled;
- Renal function test BUN, UA within 1.5 times the upper limit of normal value, creatinine clearance rate> 60ml / min;
- Subjects (or their legal representatives/guardians) must sign an informed consent form indicating that they understand the purpose of the study, understand the necessary procedures for the study, and are willing to participate in the study.
Exclusion Criteria:
- There are currently uncontrollable infections, body temperature ≥ 38.0 ° C;
- Patients with previous malignant tumors that have not been cured or have bone marrow metastasis;
- Patients with prophylactic antibiotics;
- Accepting other test drugs at the same time or participating in other clinical trials;
- Those who are allergic to this product or other genetically engineered E. coli-derived biological products;
- The patient has any myelodysplastic and other blood system diseases;
- Patients who have received hematopoietic stem cell transplantation or organ transplantation;
- The patient has a severe mental or neurological condition that affects informed consent and/or adverse reaction presentation or observation.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: PEG-rhG-CSF
Jin Youli(PEG-rhG-CSF): The dose is determined according to the patient's weight. Those who weighed more than ≥45kg were given 6mg/time, and those who were <45kg or less were given 3mg/time. Administration method: Subcutaneous injection, the lower edge of the deltoid muscle of both arms is preferentially selected, and each injection is injected once every chemotherapy cycle. Dosing time: 48 h after chemotherapy. |
Subjects with newly diagnosed small cell lung cancer who met the inclusion/exclusion criteria were prophylactically administered the test drug PEG-rhG-CSF 48 h after chemotherapy. Jin Youli(PEG-rhG-CSF): The dose is determined according to the patient's weight. Those who weighed more than ≥45kg were given 6mg/time, and those who were <45kg or less were given 3mg/time. Administration method: Subcutaneous injection, the lower edge of the deltoid muscle of both arms is preferentially selected, and each injection is injected once every chemotherapy cycle. Dosing time: 48 h after chemotherapy. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
The incidence of grade III/IV neutropenia in the first cycle of PEG-rhG-CSF.
Periodo de tiempo: through first cycle of PEG-rhG-CSF,an average of 1 month
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The incidence of grade III/IV neutropenia in the first cycle of PEG-rhG-CSF.
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through first cycle of PEG-rhG-CSF,an average of 1 month
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The incidence of grade III/IV neutropenia in the second cycle of PEG-rhG-CSF.
Periodo de tiempo: through second cycle of PEG-rhG-CSF,an average of 1 month
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The incidence of grade III/IV neutropenia in the second cycle of PEG-rhG-CSF.
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through second cycle of PEG-rhG-CSF,an average of 1 month
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
The incidence of febrile neutropenia in cycles 1 and 2
Periodo de tiempo: through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
|
Febrile neutropenia (FN) is defined as oral temperature >38.3 ° C (underarm temperature >38.1 ° C) or continuous measurement of oral temperature >38 ° C (underarm temperature >37.8 ° C) in 2 h, and ANC <0.5×10^9/L, or expected to be <0.5×10^9/L
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through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
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The ANC recovery time in cycles 1 and 2
Periodo de tiempo: through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
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Defined as the patients who appear ANC<2.0×10^9/L,from the first day of chemotherapy, to the time of ANC≥ 2.0×10^9/L, take the median.
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through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
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The incidence of infection
Periodo de tiempo: up to 30 days after the patient study completion
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up to 30 days after the patient study completion
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The incidence of antibiotic use
Periodo de tiempo: up to 30 days after the patient study completion
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up to 30 days after the patient study completion
|
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Incidence of chemotherapy dose adjustment due to neutropenia
Periodo de tiempo: through the study completion,an average of 3 months
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through the study completion,an average of 3 months
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Chemotherapy delay time
Periodo de tiempo: through the study completion,an average of 3 months
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through the study completion,an average of 3 months
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Incidence of chemotherapy delay caused by neutropenia
Periodo de tiempo: through the study completion,an average of 3 months
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through the study completion,an average of 3 months
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The duration of febrile neutropenia in cycles 1 and 2
Periodo de tiempo: through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
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through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Incidence and severity of adverse events
Periodo de tiempo: through the study completion,an average of 3 months
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All adverse events will be recorded from the time of signing the informed consent form to 30 days after the last dose.
Adverse events 30 days after the last dose, only those adverse events associated with the study drug were recorded.
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through the study completion,an average of 3 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
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
Otros números de identificación del estudio
- CSPC-JYL-SCLC-01
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. .
Ensayos clínicos sobre PEG-rhG-CSF
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Sun Yat-sen UniversityJiangsu HengRui Medicine Co., Ltd.Aún no reclutando
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Xiamen Amoytop Biotech Co., Ltd.Cancer Institute and Hospital, Chinese Academy of Medical SciencesTerminadoNeoplasia maligna no mieloidePorcelana
-
Adello Biologics, LLCinVentiv Health ClinicalTerminadoVoluntarios SaludablesEstados Unidos
-
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Hebei Medical University Fourth HospitalDesconocido
-
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Beijing Friendship HospitalDesconocidoSíndrome hemofagocíticoPorcelana
-
Zhongnan HospitalAún no reclutandoFactor estimulante de colonias de granulocitosPorcelana
-
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Terminado