An interventional study of PEG-rhG-CSF in Small Cell Lung Cancer and PEG-rhG-CSF, sponsored by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2018-12-19.
Sponsored by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. · Not applicable, Interventional, and Prevention
Evaluation of the efficacy and safety of Jinyouli in preventing neutropenia in multiple chemotherapy cycles in elderly patients with small cell lung cancer through a multicenter, open, one-arm study Subjects with newly diagnosed small cell lung cancer who met the inclusion/exclusion criteria, chemotherapy regimen: etoposide: 100 mg/m2, d1-3, carboplatin: AUC=5, d1, q21d, prophylactic use test 48 h after chemotherapy Drug PEG-rhG-CSF.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 61 is close to the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. is the lead sponsor of 26 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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.
Drug: 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.
The incidence of grade III/IV neutropenia in the first cycle of PEG-rhG-CSF.
The incidence of grade III/IV neutropenia in the first cycle of PEG-rhG-CSF.
Time frame: through first cycle of PEG-rhG-CSF,an average of 1 month
The incidence of grade III/IV neutropenia in the second cycle of PEG-rhG-CSF.
The incidence of grade III/IV neutropenia in the second cycle of PEG-rhG-CSF.
Time frame: through second cycle of PEG-rhG-CSF,an average of 1 month
The incidence of febrile neutropenia in cycles 1 and 2
Febrile neutropenia (FN) is defined as oral temperature \>38.3 ° C (underarm temperature \>38.1 ° C) or continuous measurement of oral temperature \>38 ° C (underarm temperature \>37.8 ° C) in 2 h, and ANC \<0.5×10\^9/L, or expected to be \<0.5×10\^9/L
Time frame: through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
The ANC recovery time in cycles 1 and 2
Defined as the patients who appear ANC\<2.0×10\^9/L，from the first day of chemotherapy, to the time of ANC≥ 2.0×10\^9/L, take the median.
Time frame: through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
The incidence of infection
Time frame: up to 30 days after the patient study completion
The incidence of antibiotic use
Time frame: up to 30 days after the patient study completion
Incidence of chemotherapy dose adjustment due to neutropenia
Time frame: through the study completion,an average of 3 months
Chemotherapy delay time
Time frame: through the study completion,an average of 3 months
Incidence of chemotherapy delay caused by neutropenia
Time frame: through the study completion,an average of 3 months
The duration of febrile neutropenia in cycles 1 and 2
Time frame: through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
Incidence and severity of adverse events
All adverse events will be recorded from the time of signing the informed consent form to 30 days after the last dose. Adverse events 30 days after the last dose, only those adverse events associated with the study drug were recorded.
Time frame: through the study completion,an average of 3 months
This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.