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

CSPC Pharmaceutical Group

Status and phase: Completed; Phase 4

Conditions: Malignant Solid Tumors

Treatments: Drug: PEG-rhG-CSF

Study type: Interventional

Funder types: Industry

Identifiers

NCT02805166

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

Details and patient eligibility

About

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.

Enrollment: 420 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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420 participants in 1 patient group

PEG-rhG-CSF

Experimental group

Description:

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.

Treatment:

Drug: PEG-rhG-CSF