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| Name | Class |
|---|---|
| Peking University Cancer Hospital & Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG-rhG-CSF | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-rhG-CSF | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | through second cycle of PEG-rhG-CSF,an average of 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | through 1-2 cycles of PEG-rhG-CSF,an average of 2 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | through the study completion,an average of 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Zhao, PhD | Contact | 86-010-88196456 | ohjerry@163.com | |
| Hanxiao Chen | Contact | 18810526948 | Hanxiao0628@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bejing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C423652 | pegylated granulocyte colony-stimulating factor |
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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.
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| 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. | through 1-2 cycles of PEG-rhG-CSF,an average of 2 month |
| The incidence of infection | up to 30 days after the patient study completion |
| The incidence of antibiotic use | up to 30 days after the patient study completion |
| Incidence of chemotherapy dose adjustment due to neutropenia | through the study completion,an average of 3 months |
| Chemotherapy delay time | through the study completion,an average of 3 months |
| Incidence of chemotherapy delay caused by neutropenia | through the study completion,an average of 3 months |
| The duration of febrile neutropenia in cycles 1 and 2 | through 1-2 cycles of PEG-rhG-CSF,an average of 2 month |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |