PEG-rhG-CSF in Elderly Patients With Small Cell Lung Cancer Receiving Chemotherapy
16 décembre 2018 mis à jour par: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
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
Evaluation of the efficacy and safety of Jinyouli in preventing neutropenia in multiple chemotherapy cycles in elderly patients with small cell lung cancer through a multicenter, open, one-arm study Subjects with newly diagnosed small cell lung cancer who met the inclusion/exclusion criteria, chemotherapy regimen: etoposide: 100 mg/m2, d1-3, carboplatin: AUC=5, d1, q21d, prophylactic use test 48 h after chemotherapy Drug PEG-rhG-CSF.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Anticipé)
61
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Beijing
-
Beijing, Beijing, Chine, 100142
- Recrutement
- Bejing Cancer Hospital
-
Contact:
- Jun Zhao, PhD
- Numéro de téléphone: 86-010-88196456
- E-mail: ohjerry@163.com
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
70 ans et plus (Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The incidence of grade III/IV neutropenia in the first cycle of PEG-rhG-CSF.
Délai: through first cycle of PEG-rhG-CSF,an average of 1 month
|
The incidence of grade III/IV neutropenia in the first cycle of PEG-rhG-CSF.
|
through first 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.
Délai: 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.
|
through second cycle of PEG-rhG-CSF,an average of 1 month
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The incidence of febrile neutropenia in cycles 1 and 2
Délai: 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
|
through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
|
|
The ANC recovery time in cycles 1 and 2
Délai: 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.
|
through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
|
|
The incidence of infection
Délai: up to 30 days after the patient study completion
|
up to 30 days after the patient study completion
|
|
|
The incidence of antibiotic use
Délai: up to 30 days after the patient study completion
|
up to 30 days after the patient study completion
|
|
|
Incidence of chemotherapy dose adjustment due to neutropenia
Délai: through the study completion,an average of 3 months
|
through the study completion,an average of 3 months
|
|
|
Chemotherapy delay time
Délai: 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
Délai: through the study completion,an average of 3 months
|
through the study completion,an average of 3 months
|
|
|
The duration of febrile neutropenia in cycles 1 and 2
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence and severity of adverse events
Délai: 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.
|
through the study completion,an average of 3 months
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
5 décembre 2018
Achèvement primaire (Anticipé)
1 décembre 2019
Achèvement de l'étude (Anticipé)
1 février 2020
Dates d'inscription aux études
Première soumission
10 décembre 2018
Première soumission répondant aux critères de contrôle qualité
12 décembre 2018
Première publication (Réel)
17 décembre 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
19 décembre 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
16 décembre 2018
Dernière vérification
1 décembre 2018
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CSPC-JYL-SCLC-01
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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