PEG-rhG-CSF in Elderly Patients With Small Cell Lung Cancer Receiving Chemotherapy
NCT ID: NCT03776604
Last Updated: 2018-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
61 participants
INTERVENTIONAL
2018-12-05
2020-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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PEG-rhG-CSF
Jin Youli(PEG-rhG-CSF): The dose is determined according to the patient's weight. Those who weighed more than ≥45kg were given 6mg/time, and those who were \<45kg or less were given 3mg/time. Administration method: Subcutaneous injection, the lower edge of the deltoid muscle of both arms is preferentially selected, and each injection is injected once every chemotherapy cycle.
Dosing time: 48 h after chemotherapy.
PEG-rhG-CSF
Subjects with newly diagnosed small cell lung cancer who met the inclusion/exclusion criteria were prophylactically administered the test drug PEG-rhG-CSF 48 h after chemotherapy.
Jin Youli（PEG-rhG-CSF）: The dose is determined according to the patient's weight. Those who weighed more than ≥45kg were given 6mg/time, and those who were \<45kg or less were given 3mg/time. Administration method: Subcutaneous injection, the lower edge of the deltoid muscle of both arms is preferentially selected, and each injection is injected once every chemotherapy cycle.
Dosing time: 48 h after chemotherapy.
Interventions
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PEG-rhG-CSF
Subjects with newly diagnosed small cell lung cancer who met the inclusion/exclusion criteria were prophylactically administered the test drug PEG-rhG-CSF 48 h after chemotherapy.
Jin Youli（PEG-rhG-CSF）: The dose is determined according to the patient's weight. Those who weighed more than ≥45kg were given 6mg/time, and those who were \<45kg or less were given 3mg/time. Administration method: Subcutaneous injection, the lower edge of the deltoid muscle of both arms is preferentially selected, and each injection is injected once every chemotherapy cycle.
Dosing time: 48 h after chemotherapy.
Eligibility Criteria
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Inclusion Criteria
* Small cell lung cancer patients diagnosed by histopathology or cytology;
* ECOG = 0-1;
* The estimated survival period is more than 3 months;
* No obvious signs of hematological disease, defined as Hb≥90g/dL, WBC≥4.0×10\^9/L, ANC≥2×10\^9/L, PLT≥100×10\^9/L before enrollment. And no bleeding tendency;
* No obvious abnormalities were observed in the electrocardiogram examination;
* Liver function tests ALT, AST, TBIL indicators are within 2.5 times the upper limit of normal values. If due to liver metastasis, the above indicators should be within 5 times of the upper limit of normal. If LDH is elevated due to non-tumor causes, LDH should be ≤ 2.5 times the upper limit of normal; if LDH is elevated due to tumor, it can be enrolled;
* Renal function test BUN, UA within 1.5 times the upper limit of normal value, creatinine clearance rate\> 60ml / min;
* Subjects (or their legal representatives/guardians) must sign an informed consent form indicating that they understand the purpose of the study, understand the necessary procedures for the study, and are willing to participate in the study.
Exclusion Criteria
* Patients with previous malignant tumors that have not been cured or have bone marrow metastasis;
* Patients with prophylactic antibiotics;
* Accepting other test drugs at the same time or participating in other clinical trials;
* Those who are allergic to this product or other genetically engineered E. coli-derived biological products;
* The patient has any myelodysplastic and other blood system diseases;
* Patients who have received hematopoietic stem cell transplantation or organ transplantation;
* The patient has a severe mental or neurological condition that affects informed consent and/or adverse reaction presentation or observation.
70 Years
ALL
No
Sponsors
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Peking University Cancer Hospital & Institute
OTHER
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Bejing Cancer Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Jun Zhao, PhD
Role: primary
Other Identifiers
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CSPC-JYL-SCLC-01
Identifier Type: -
Identifier Source: org_study_id