- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Beijing
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Beijing, Beijing, China, 100142
- Recrutamento
- Bejing Cancer Hospital
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Contato:
- Jun Zhao, PhD
- Número de telefone: 86-010-88196456
- E-mail: ohjerry@163.com
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
The incidence of grade III/IV neutropenia in the first cycle of PEG-rhG-CSF.
Prazo: 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.
Prazo: through second cycle of PEG-rhG-CSF,an average of 1 month
|
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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
The incidence of febrile neutropenia in cycles 1 and 2
Prazo: 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
Prazo: through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
|
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
Prazo: 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
Prazo: 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
Prazo: through the study completion,an average of 3 months
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through the study completion,an average of 3 months
|
|
Chemotherapy delay time
Prazo: through the study completion,an average of 3 months
|
through the study completion,an average of 3 months
|
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Incidence of chemotherapy delay caused by neutropenia
Prazo: 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
Prazo: through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
|
through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Incidence and severity of adverse events
Prazo: through the study completion,an average of 3 months
|
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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CSPC-JYL-SCLC-01
Informações sobre medicamentos e dispositivos, documentos de estudo
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CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Concluído
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