Clinical trial NCT03846414: Real World Study of PEG-rhG-CSF in Prevention of Chemotherapy-induced Neutropenia
Official title: Real World Study of PEGylated Recombinant Human Granulocyte Stimulating Factor(PEG-rhG-CSF) in Prevention of Chemotherapy-induced Neutropenia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chemotherapy-induced Neutropenia
Myelosuppression
Keywords: PEG-rhG-CSF
Pegfilgrastim
Lead sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-02-19
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1000 patients with non-myeloid malignancy who is planned to receive PEG-rhG-CSF for CIN prevention and 500 patients with non-myeloid malignancy who is planned to receive rhG-CSF for CIN prevention or treatment were prospectively recruited.

Brief summary: The aim of this study is to observe and evaluate the cost-effectiveness,efficacy and safety of PEG-rhG-CSF in preventing chemotherapy-induced neutropenia(CIN) of cancer patients in the real world.1000 patients with non-myeloid malignancy who is planned to receive PEG-rhG-CSF for CIN prevention and 500 patients with non-myeloid malignancy who is planned to receive rhG-CSF for CIN prevention or treatment were prospectively recruited.The primary outcome was cost-effectiveness and second outcome was febrile neutropenia,the incidence and duration of grade IV neutropenia,chemotherapy delay,incidence of reduced dose of chemotherapy and relative dose intensity of chemotherapy.


Eligibility criteria: Inclusion Criteria:

1. Patients' age≥18 years old, male or female
2. Diagnosis of non-myeloid malignant solid tumors
3. Patients are planned to perform chemotherapy and preventive use the PEG-rhG-CSF or preventive or therapeutic use of rhG-CSF after chemotherapy
4. Patients' mental status are well, could understand the study and willing to participate the study, sign the informed consent form
5. The investigator believes that patients can benefit from this study

Exclusion Criteria:

1. Patients who have been confirmed to be allergic to Jinyouli® or rhG-CSF or its excipients
2. Pregnant or lactating women and women who plan to be pregnant during clinical observation
3. Other patients that the doctor believe not suitable for inclusion

Primary outcomes:
measure: Cost-Effectiveness
timeFrame: through the chemotherapy cycles of PEG-rhG-CSF or rhG-CSF treatment,an average of 3 month
Secondary outcomes:
measure: The incidence of febrile neutropenia
timeFrame: From date of randomization until the date of the study completion,an average of 3 month
measure: The incidence of grade IV neutropenia
timeFrame: From date of randomization until the date of the study completion,an average of 3 month
measure: The duration of grade IV neutropenia in every chemotherapy cycle
timeFrame: From date of randomization until the date of the study completion,an average of 3 month
measure: The incidence of the chemotherapy delay
timeFrame: From date of randomization until the date of the study completion,an average of 3 month
measure: The duration of the chemotherapy delay in every chemotherapy cycle
timeFrame: From date of randomization until the date of the study completion,an average of 3 month
measure: The incidence of the dose reduction
timeFrame: From date of randomization until the date of the study completion,an average of 3 month
measure: Relative chemotherapy dose intensity in every chemotherapy cycle
timeFrame: From date of randomization until the date of the study completion,an average of 3 month
Other outcomes:
measure: Incidence of adverse events
timeFrame: From date of randomization until the date of the study completion,an average of 3 month
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Study officials:
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