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

• Status: Unknown status
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Air Force Military Medical University, China; Fourth Military Medical University

Criteria

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.