NCT03206684

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Air Force Military Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2017-08-01
• Primary completion: 2018-07-01
• Completion: 2018-09-01
• First posted: 2017-07-02
• Last updated: 2017-08-28

Locations

1 site across 1 country: China