To Evaluate the Efficacy and Safety of PEG-rhG-CSF(Jinyouli®) in Reducing Neutropenia in Patients With Cervical Cancer

Last updated: August 25, 2017
Sponsor: Fourth Military Medical University
Overall Status: Trial Status Unknown

Phase

4

Condition

Cervical Cancer

Pelvic Cancer

Vaginal Cancer

Treatment

N/A

Clinical Study ID

NCT03206684
CSPC-JYL-CC-01
  • Ages 18-70
  • All Genders

Study Summary

A Prospective, open, randomized, controlled clinical study to evaluate the efficacy and safety of PEG-rhG-CSF(PEGylated recombinant human granulocyte stimulating factor injection) in reducing neutropenia during TP(docetaxel+cisplatin) regiment simultaneous radiochemotherapy and adjuvant chemotherapy in patients with cervical cancer

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18, ≤70 years old;

  2. Cervical cancer patients diagnosed by histopathology;

  3. Need to receive multi-cycle radical concurrent radiochemotherapy;

  4. FN risk > 20% if rhG-CSF was not accepted; High risk factors associated with FN andplaned to use the same protocol in subsequent cycles(docetaxel+cisplatin regimen);

  5. Performance status score(KPS)≥70;

  6. No obvious blood system disease,absolute neutrophil count(ANC)≥ 1.5×10^9/L, plateletcount≥80×10^9 /L, hemoglobin(Hb)≥75 g/L, and no bleeding tendency;

  7. The patient signs the informed consent.

Exclusion

Exclusion Criteria:

  1. With infection difficult to control, or received system antibiotic treatment within 72h before chemotherapy;

  2. Any bone marrow abnormalities and other hematopoietic ;

  3. Had received bone marrow or hematopoietic stem cell transplantation within 3 months;

  4. with other malignancies not cure, or with brain metastases;

  5. Liver function tests:total bilirubin(TBIL), alanine aminotransferase (ALT) andaspartate aminotransferase (AST) were all ≥2.5 times normal upper limit.

  6. Renal function tests: serum creatinine (Cr)> 1.5 times normal upper limit;

  7. Allergic to the drugs or other genetic engineering biological products fromEscherichia coli;

  8. Suffering from mental or neurological disorders;

  9. Investigator think it is not suitable for recruiting.

Study Design

Total Participants: 20
Study Start date:
August 01, 2017
Estimated Completion Date:
September 30, 2018

Connect with a study center

  • Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University

    Xi'an, Shaanxi 710032
    China

    Site Not Available

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