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

The Multi-center,Open-label,Single Arm Phase IV Clinical Trial of Efficacy and Safety of PEG-rhG-CSF in Patients With Lung Cancer,Head and Neck Cancer,Colorectal Cancer,Ovarian Cancer and the Other Cancer Receiving Chemotherapy

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02805166

Enrollment

420

Registered

2016-06-17

Start date

2013-04-30

Completion date

2016-02-29

Last updated

2016-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Solid Tumors

Keywords

PEG-rhG-CSF

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.

Interventions

DRUGPEG-rhG-CSF

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The occurrence rate of adverse event during at least three consecutive cycles chemotherapy	up to 30 days after the patient study completion
The severity of adverse event during at least three consecutive cycles chemotherapy	up to 30 days after the patient study completion

Secondary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026