NCT04773327

Efficacy and Safety of PEG-rhG-CSF in the Prevention of Neutropenia After Chemo in Pts With Gynecological Malignancies

A Multicenter, Randomized Controlled, Open Clinical Study of the Efficacy and Safety of PEG-rhG-CSF in the Prevention of Neutropenia After Chemotherapy in Patients With Gynecological Malignancies

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Xiaohua Wu MD · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a multi-center, forward-looking, open, randomized, controlled clinical trial. This study aims to analyze the effects of Mecapegfilgrastim Injection prevention versus non-prevention for neutropenia in ovarian cancer, cervical cancer, endometrial cancer patients after chemical therapy. Patients are randomized into study group and control group. All patients receive PTX+platinum chemotherapy of 3 weeks. In study group, patients accept PEG-rhG-CSF 24-48 hours from the chemotherapy. While the control group patients are only observed closely. Patient receive three courses of treatment. The primary end is the incidence of 3/4 level neutropenia in three courses of chemotherapy. The secondary ends include: the incidences and duration of neutropenia in every course of chemotherapy, the incidences of FN in three courses and every course of chemotherapy, the incidences of infection in three courses and every course of chemotherapy, the delay time of the next cycle of chemotherapy due to FN or infection, the RDI of the second and third cycles of chemotherapy, adverse events related to G-CSF, quality of life, cost of medicine and admitting.

Conditions

• Gynecologic Malignant Tumor

Interventions

Type	Name	Description
OTHER	Mecapegfilgrastim Injection	24-48h after the end of antitumor drug administration in each chemotherapy cycle, Mecapegfilgrastim was injected subcutaneously, 6mg/ time, once/cycle

Timeline

• Start date: 2021-05-01
• Primary completion: 2022-06-01
• Completion: 2022-08-01
• First posted: 2021-02-26
• Last updated: 2021-02-26

Locations

1 site across 1 country: China