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

C

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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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