PEG-rhG-CSF in Patients With Malignant Solid Tumors Receiving Chemotherapy
- Registration Number
- NCT02805166
- Lead Sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
- Brief Summary
The purpose of this study is to estimate the safety and efficacy of PEG-rhG-CSF in patients with lung cancer,head and neck cancer,colorectal cancer,and ovarian cancer receiving multi-cycle chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 420
Inclusion Criteria
- Patients with age ≥ 18 years
- diagnosis of lung cancer,head and neck cancer,colorectal cancer,ovarian cancer
- Karnofsky Performance Status ≥ 70
- life expectancy of at least 3 months
- Written informed consent are acquired
Exclusion Criteria
- uncontrolled infection,Temperature is 38.0 ℃ or higher
- pregnancy
- Other situations that investigators consider as contra-indication for this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PEG-rhG-CSF PEG-rhG-CSF patients received a single dose of 100 ug/kg of PEG-rhG-CSF(pegfilgrastim), on the basis of actual body weight, as a single subcutaneous injection on day 3 after chemotherapy.
- Primary Outcome Measures
Name Time Method The severity of adverse event during at least three consecutive cycles chemotherapy up to 30 days after the patient study completion The occurrence rate of adverse event during at least three consecutive cycles chemotherapy up to 30 days after the patient study completion
- Secondary Outcome Measures
Name Time Method the non-occurrence rate of grade IV neutropenia (ANC <0.5 x 10^9/L)during at least three consecutive cycles chemotherapy through the study completion,an average of 5 months the duration of grade IV neutropenia(ANC <0.5 x 10^9/L) during at least three consecutive cycles chemotherapy through the study completion,an average of 5 months