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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Drug: PEG-rhG-CSF
* Drug: rhG-CSF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18, ≤70 years old; Cervical cancer patients diagnosed by histopathology; Need to receive multi-cycle radical concurrent radiochemotherapy; 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)； Performance status score(KPS)≥70; 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; The patient signs the informed consent. Exclusion Criteria: With infection difficult to control, or received system antibiotic treatment within 72 h before chemotherapy; Any bone marrow abnormalities and other hematopoietic ; Had received bone marrow or hematopoietic stem cell transplantation within 3 months; with other malignancies not cure, or with brain metastases; Liver function tests:total bilirubin(TBIL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were all ≥2.5 times normal upper limit. Renal function tests: serum creatinine (Cr)> 1.5 times normal upper limit; Allergic to the drugs or other genetic engineering biological products from Escherichia coli; Suffering from mental or neurological disorders; Investigator think it is not suitable for recruiting.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEG-rhG-CSF<br>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<br>* 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.<br>* Other names: PEG-rhG-CSF single-dose administered;|
| Active Comparator: rhG-CSF<br>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<br>* 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.<br>* Other names: rhG-CSF daily administered;|

What is the study measuring?
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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 |