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PEG-rhG-CSF in Elderly Patients With Small Cell Lung Cancer Receiving Chemotherapy

16. december 2018 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

61

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Beijing
      • Beijing, Beijing, Kina, 100142
        • Rekruttering
        • Bejing Cancer Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

70 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: PEG-rhG-CSF

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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Samarbejdspartnere

Peking University Cancer Hospital & Institute

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. december 2018

Primær færdiggørelse (Forventet)

1. december 2019

Studieafslutning (Forventet)

1. februar 2020

Datoer for studieregistrering

Først indsendt

10. december 2018

Først indsendt, der opfyldte QC-kriterier

12. december 2018

Først opslået (Faktiske)

17. december 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. december 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. december 2018

Sidst verificeret

1. december 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CSPC-JYL-SCLC-01

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