solid tumor
Conditions
Interventions
experimental group:Prophylactic use of PEG-rhG-CSF injection after postoperative radiotherapy
Sponsors
Zhengzhou Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged from 18-70 years. male or female; 2. KPS >= 80; 3.The patient was diagnosed as solid tumor by histopathology; 4.Expected survival time >=6 months; 5.There was neutropenia during early chemotherapy; 6.According to RECIST 1.1 criteria, at least one measurable lesion is present, and a measurable disease is defined as at least one lesion that can be accurately measured on at least one layer (long diameter is recorded);When measured by computed tomography (CT), magnetic resonance imaging (MRI), each lesion must be > 10mm and lymph nodes must be > 15mm on the short axis. According to RECIST version 1.1, patients must have at least one "target" lesion to evaluate for response to the protocol; 7.The function of major organs is normal, that is, the following criteria are met: (1)Blood routine parameters: WBC >= 4.0 x 10^9/L; ANC >= 1.5 x 10^9/L; Hb >= 90g/L; PLT >= 100 x 10^9/L; (2)The biochemical tests must meet the following criteria: TBIL =60 mL /min; 8.Women who are not menopausal or surgically sterilized: consent to abstinence or use of an effective contraceptive method during treatment and for at least 6 months after the last administration in the study; 9. Sign written informed consent before enrollment.
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to thiopefilgrastim, polyethylene glycol recombinant human granulocyte stimulating factor, recombinant human granulocyte stimulating factor and other preparations expressed by Escherichia coli; 2. Severe acute infection that has not been controlled; or purulent and chronic infection with persistent wound healing; 3. With other comorbidities such as myocardial infarction, severe arrhythmia, severe cerebrovascular disease, psychosis and uncontrolled diabetes, persistent arrhythmia (CTCAE standard grade 2 and above), atrial fibrillation of any degree, between Qt period prolongation (over 470 milliseconds in women), refractory hypertension (blood pressure remains higher than 150/100 mm Hg after optimal medical therapy); 4. Those who suffer from neurological, mental diseases or mental disorders that are not easy to control, have poor compliance, and cannot cooperate and describe treatment responses; 5. Other severe, acute or chronic medical diseases or laboratory abnormalities that may increase the risk associated with participating in the study, or may interfere with the interpretation of the study results, according to the investigator's opinion; 6. Pregnant or lactating women; 7. Patients who participate in other clinical trials at the same time; 8. There are other situations that the researchers think are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of grade III/IV neutropenia during the radiotherapy cycle following the administration of tipefegestine; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of grade III/IV neutropenia during the radiotherapy cycle after thiephegestine administration;The ANC lowest;Number of rhG-CSF used; | — |
Countries
China
Contacts
Public ContactHan Quanxiang
Zhengzhou Central Hospital
Outcome results
None listed