PEG-rhG-CSF in Elderly Patients With Small Cell Lung Cancer Receiving Chemotherapy
16. Dezember 2018 aktualisiert von: 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.
Studienübersicht
Status
Unbekannt
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Voraussichtlich)
61
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Beijing
-
Beijing, Beijing, China, 100142
- Rekrutierung
- Bejing Cancer Hospital
-
Kontakt:
- Jun Zhao, PhD
- Telefonnummer: 86-010-88196456
- E-Mail: ohjerry@163.com
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
70 Jahre und älter (Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
The incidence of grade III/IV neutropenia in the first cycle of PEG-rhG-CSF.
Zeitfenster: 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.
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
The incidence of febrile neutropenia in cycles 1 and 2
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: up to 30 days after the patient study completion
|
up to 30 days after the patient study completion
|
|
|
The incidence of antibiotic use
Zeitfenster: 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
Zeitfenster: through the study completion,an average of 3 months
|
through the study completion,an average of 3 months
|
|
|
Chemotherapy delay time
Zeitfenster: through the study completion,an average of 3 months
|
through the study completion,an average of 3 months
|
|
|
Incidence of chemotherapy delay caused by neutropenia
Zeitfenster: 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
Zeitfenster: 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
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Incidence and severity of adverse events
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
5. Dezember 2018
Primärer Abschluss (Voraussichtlich)
1. Dezember 2019
Studienabschluss (Voraussichtlich)
1. Februar 2020
Studienanmeldedaten
Zuerst eingereicht
10. Dezember 2018
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
12. Dezember 2018
Zuerst gepostet (Tatsächlich)
17. Dezember 2018
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
19. Dezember 2018
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
16. Dezember 2018
Zuletzt verifiziert
1. Dezember 2018
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CSPC-JYL-SCLC-01
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .