PEG-rhG-CSF in Patients With Malignant Solid Tumors Receiving Chemotherapy

Phase 4

Completed

• Conditions: Malignant Solid Tumors
• Interventions: Drug: PEG-rhG-CSF

• 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

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-06
• Study First Submitted: 2016-06-13
• Study First Submitted QC: 2016-06-16
• Last Update Submitted: 2016-06-16
• Study First Posted: 2016-06-17
• Last Update Posted: 2016-06-17

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