PEG-rhG-CSF in Elderly Patients With Small Cell Lung Cancer Receiving Chemotherapy
16. desember 2018 oppdatert av: 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.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
61
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Beijing
-
Beijing, Beijing, Kina, 100142
- Rekruttering
- Bejing Cancer Hospital
-
Ta kontakt med:
- Jun Zhao, PhD
- Telefonnummer: 86-010-88196456
- E-post: ohjerry@163.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
70 år og eldre (Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The incidence of grade III/IV neutropenia in the first cycle of PEG-rhG-CSF.
Tidsramme: 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.
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The incidence of febrile neutropenia in cycles 1 and 2
Tidsramme: 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
Tidsramme: 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
Tidsramme: up to 30 days after the patient study completion
|
up to 30 days after the patient study completion
|
|
|
The incidence of antibiotic use
Tidsramme: 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
Tidsramme: through the study completion,an average of 3 months
|
through the study completion,an average of 3 months
|
|
|
Chemotherapy delay time
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence and severity of adverse events
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
5. desember 2018
Primær fullføring (Forventet)
1. desember 2019
Studiet fullført (Forventet)
1. februar 2020
Datoer for studieregistrering
Først innsendt
10. desember 2018
Først innsendt som oppfylte QC-kriteriene
12. desember 2018
Først lagt ut (Faktiske)
17. desember 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. desember 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. desember 2018
Sist bekreftet
1. desember 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CSPC-JYL-SCLC-01
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .