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

A Prospective, Open, Randomized, Controlled Clinical Study to Evaluate the Efficacy and Safety of PEG-rhG-CSF in Reducing Neutropenia in Patients With Cervical Cancer

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

Study Overview

• Status: Unknown
• Conditions: Cervical Cancer
• Intervention / Treatment: Drug: PEG-rhG-CSF; Drug: rhG-CSF

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 and planed 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, platelet count≥80×10^9 /L, hemoglobin（Hb）≥75 g/L, and no bleeding tendency;
7. The patient signs the informed consent.

Exclusion Criteria:

1. With infection difficult to control, or received system antibiotic treatment within 72 h 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) and aspartate 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 from Escherichia coli;
8. Suffering from mental or neurological disorders;
9. Investigator think it is not suitable for recruiting.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEG-rhG-CSF; PEG-rhG-CSF single-dose was administered subcutaneously 48h after chemotherapy，with patients' weight ≥ 45kg were given 6mg once per chemotherapy cycle, weight <45kg were given 3mg once per chemotherapy cycle.	Drug: PEG-rhG-CSF; PEG-rhG-CSF single-dose was administered subcutaneously 48h after chemotherapy，weight ≥ 45kg were given 6mg once per chemotherapy cycle, weight <45kg were given 3mg once per chemotherapy cycle.; Other Names: PEG-rhG-CSF single-dose administered
Active Comparator: rhG-CSF; rhG-CSF was daily administered subcutaneously 48h after chemotherapy，weight≥45kg were given 300μg/d, weight<45kg were given 150μg/d,continuous injection for 3-5 days until the absolute neutrophils count≥2×10^9/L.	Drug: rhG-CSF; rhG-CSF was administered subcutaneously 48h after chemotherapy，weight≥45kg were given 300μg/d, weight<45kg were given 150μg/d,continuous injection for 3-5 days until the absolute neutrophils count≥2×10^9/L.; Other Names: rhG-CSF daily administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of III/IV neutropenia	The incidence of III/IV neutropenia in each chemotherapy cycle	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of FN	Incidence of febrile neutropenia (FN) in each chemotherapy cycle	3 months
Proportion of chemotherapy dose adjustment	Proportion of chemotherapy dose adjustment due to neutropenia	3 months

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China
• Investigators: Principal Investigator: Mei Shi, MD, Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2017
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: June 30, 2017
• First Submitted That Met QC Criteria: June 30, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): August 28, 2017
• Last Update Submitted That Met QC Criteria: August 25, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Uterine Cervical Neoplasms; Neutropenia
• Other Study ID Numbers: CSPC-JYL-CC-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No