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

NCT ID: NCT02805166

Last Updated: 2016-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2016-02-29

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.

Conditions

Malignant Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PEG-rhG-CSF

Intervention Type: DRUG

Interventions

PEG-rhG-CSF

Intervention Type: DRUG

Other Intervention Names

pegfilgrastim

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CSPC-PGC-IV-01/CSPC-PGC-IV-02

Identifier Type: -

Identifier Source: org_study_id