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Efficacy and Safety of PEG-rhG-CSF in the Prevention of Neutropenia After Chemo in Pts With Gynecological Malignancies

24. februar 2021 opdateret af: Xiaohua Wu MD

A Multicenter, Randomized Controlled, Open Clinical Study of the Efficacy and Safety of PEG-rhG-CSF in the Prevention of Neutropenia After Chemotherapy in Patients With Gynecological Malignancies

This study is a multi-center, forward-looking, open, randomized, controlled clinical trial. This study aims to analyze the effects of Mecapegfilgrastim Injection prevention versus non-prevention for neutropenia in ovarian cancer, cervical cancer, endometrial cancer patients after chemical therapy.

Patients are randomized into study group and control group. All patients receive PTX+platinum chemotherapy of 3 weeks. In study group, patients accept PEG-rhG-CSF 24-48 hours from the chemotherapy. While the control group patients are only observed closely. Patient receive three courses of treatment.

The primary end is the incidence of 3/4 level neutropenia in three courses of chemotherapy.

The secondary ends include: the incidences and duration of neutropenia in every course of chemotherapy, the incidences of FN in three courses and every course of chemotherapy, the incidences of infection in three courses and every course of chemotherapy, the delay time of the next cycle of chemotherapy due to FN or infection, the RDI of the second and third cycles of chemotherapy, adverse events related to G-CSF, quality of life, cost of medicine and admitting.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

150

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Xiaohua Wu, MD&PHD
  • Telefonnummer: +862164175590
  • E-mail: alizheng@126.com

Studiesteder

  • Kina
    • Shanghai
      • Shanghai, Shanghai, Kina
        • No. 270, Dongan Road, Xuhui District, Shanghai, China
        • 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

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Ages 18-70
  • Weight ≥45 kg
  • ≤2 lines chemotherapy or postoperative adjuvant chemotherapy patients with cervical cancer, ovarian cancer and endometrial cancer
  • Receive paclitaxel combined with platinum three weeks per cycle of chemotherapy
  • With an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
  • Expected survival time of > 3 months

  • Main organ functions meet the following criteria:

    1. Hb≥75g/L; WBC≥3.0×109/L; ANC≥1.5×109/L; PLT≥80×109/L;
    2. APTT-ULN≤10s; PT-ULN≤3s; TT-ULN≤3s;
    3. ALT≤2.5×ULN; AST≤2.5×ULN; TBIL≤2.5×ULN;
    4. BUN≤1.5×ULN; Cr≤1.5×ULN; UA≤1.5×ULN；Creatinine clearance≥40mL/min;
    5. without obvious cardiac dysfunction
  • Provided consent for participation

Exclusion Criteria:

  • With uncontrollable infections or receive systemic antibiotics within 72 hours prior to chemotherapy
  • Pregnant or lactating women
  • Received bone marrow or hematopoietic stem cell transplantation within the past 3 months
  • Concurrent chemoradiotherapy
  • Presence of hematological disorders: systemic lupus erythematosus, sjogren's syndrome, rheumatic autoimmune disease, mixed and hoof tissue disease, autoimmune hemolytic anemia, leukopenia , chronic granulocyte leukemia, bone marrow dysplasia syndrome, aplastic anemia, congenital and idiopathic neutropenia, myelodysplastic syndrome, cyclic neutropenia, primary and secondary thrombocytopenic purpura, etc
  • Presence of risk of thrombus or high risk of clotting
  • Presence of psychosis, neurological disease or brain metastases from tumors
  • Presence of uncontrollable complicated disease including symptomatic congestive heart failure, uncontrollable hypertension, unstable angina pectoris, active peptic ulcer, or hemorrhagic disease
  • Presence of uncontrollable infectious diseases, active viral hepatitis, tuberculosis, HIV
  • Allergic to recombinant human granulocyte stimulating factor or other biological products of E. coli origin
  • Received clinical trials within 1 month prior to enrollment

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: PEG-rhG-CSF prevention
Mecapegfilgrastim subcutaneous injection, 6mg, 24-48h after the end of antitumor drug administration in each chemotherapy cycle,
Andet: Mecapegfilgrastim Injection
24-48h after the end of antitumor drug administration in each chemotherapy cycle, Mecapegfilgrastim was injected subcutaneously, 6mg/ time, once/cycle
Andre navne:
  • PEG- rhg - csf
Ingen indgriben: non-prevention
Only close monitoring after chemotherapy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of third/fourth level neutropenia
Tidsramme: three months
Incidence of third/fourth level neutropenia during three cycles chemotherapy
three months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of febrile neutropenia
Tidsramme: three months
Incidence of febrile neutropenia during every cycle chemotherapy
three months
The duration time of third/fourth level neutropenia
Tidsramme: three months
The duration time of third/fourth level neutropenia during three cycles chemotherapy
three months
Incidence of infection
Tidsramme: three months
Incidence of third/fourth level neutropenia during three cycles chemotherapy
three months
delay time of chemotherapy
Tidsramme: three months
The delay time of the next cycle of chemotherapy due to FN or infection
three months
RDI of chemotherapy
Tidsramme: three months
Relative dose intensity of the second and third chemotherapy
three months
Adverse events
Tidsramme: three months
Incidence of adverse events related to granulocyte colony stimulating factor according to common Terminology Criteria for Adverse Events (CTCAE) v5.0
three months

Samarbejdspartnere og efterforskere

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

Sponsor

Xiaohua Wu MD

Efterforskere

  • Ledende efterforsker: Xiaohua Wu, MD&PHD, director of gynecologic oncology

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 (Forventet)

1. maj 2021

Primær færdiggørelse (Forventet)

1. juni 2022

Studieafslutning (Forventet)

1. august 2022

Datoer for studieregistrering

Først indsendt

2. februar 2021

Først indsendt, der opfyldte QC-kriterier

24. februar 2021

Først opslået (Faktiske)

26. februar 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. februar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. februar 2021

Sidst verificeret

1. februar 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MA-GynC-II-001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

IPD-planbeskrivelse

data is available per require after approved by ethics broad

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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Kliniske forsøg med Gynecologic Malignant Tumor

Kliniske forsøg med Mecapegfilgrastim Injection

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