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

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.420 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

420

Conditions

Malignant Solid Tumors

Interventions

PEG-rhG-CSFDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The occurrence rate of adverse event during at least three consecutive cycles chemotherapy

Time frame: up to 30 days after the patient study completion

The severity of adverse event during at least three consecutive cycles chemotherapy

Time frame: up to 30 days after the patient study completion

Secondary Outcomes

the non-occurrence rate of grade IV neutropenia (ANC <0.5 x 10^9/L)during at least three consecutive cycles chemotherapy

Time frame: 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

Time frame: through the study completion,an average of 5 months

Data from ClinicalTrials.gov

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