Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2026-01-22 @ 4:27 PM
Study NCT ID:
NCT03776604
Status:
UNKNOWN
Last Update Posted:
2018-12-19
First Post:
2018-12-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PEG-rhG-CSF in Elderly Patients With Small Cell Lung Cancer Receiving Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C423652', 'term': 'pegylated granulocyte colony-stimulating factor'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 61}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2020-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-16', 'studyFirstSubmitDate': '2018-12-10', 'studyFirstSubmitQcDate': '2018-12-12', 'lastUpdatePostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence and severity of adverse events', 'timeFrame': 'through the study completion,an average of 3 months', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'The incidence of grade III/IV neutropenia in the first cycle of PEG-rhG-CSF.', 'timeFrame': 'through first cycle of PEG-rhG-CSF,an average of 1 month', 'description': 'The incidence of grade III/IV neutropenia in the first cycle of PEG-rhG-CSF.'}, {'measure': 'The incidence of grade III/IV neutropenia in the second cycle of PEG-rhG-CSF.', 'timeFrame': 'through second cycle of PEG-rhG-CSF,an average of 1 month', 'description': 'The incidence of grade III/IV neutropenia in the second cycle of PEG-rhG-CSF.'}], 'secondaryOutcomes': [{'measure': 'The incidence of febrile neutropenia in cycles 1 and 2', 'timeFrame': 'through 1-2 cycles of PEG-rhG-CSF,an average of 2 month', 'description': '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'}, {'measure': 'The ANC recovery time in cycles 1 and 2', 'timeFrame': 'through 1-2 cycles of PEG-rhG-CSF,an average of 2 month', 'description': '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.'}, {'measure': 'The incidence of infection', 'timeFrame': 'up to 30 days after the patient study completion'}, {'measure': 'The incidence of antibiotic use', 'timeFrame': 'up to 30 days after the patient study completion'}, {'measure': 'Incidence of chemotherapy dose adjustment due to neutropenia', 'timeFrame': 'through the study completion,an average of 3 months'}, {'measure': 'Chemotherapy delay time', 'timeFrame': 'through the study completion,an average of 3 months'}, {'measure': 'Incidence of chemotherapy delay caused by neutropenia', 'timeFrame': 'through the study completion,an average of 3 months'}, {'measure': 'The duration of febrile neutropenia in cycles 1 and 2', 'timeFrame': 'through 1-2 cycles of PEG-rhG-CSF,an average of 2 month'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Small Cell Lung Cancer', 'PEG-rhG-CSF']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 70 years old, gender is not limited;\n* Small cell lung cancer patients diagnosed by histopathology or cytology;\n* ECOG = 0-1;\n* The estimated survival period is more than 3 months;\n* 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;\n* No obvious abnormalities were observed in the electrocardiogram examination;\n* 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;\n* Renal function test BUN, UA within 1.5 times the upper limit of normal value, creatinine clearance rate\\> 60ml / min;\n* 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.\n\nExclusion Criteria:\n\n* There are currently uncontrollable infections, body temperature ≥ 38.0 ° C;\n* Patients with previous malignant tumors that have not been cured or have bone marrow metastasis;\n* Patients with prophylactic antibiotics;\n* Accepting other test drugs at the same time or participating in other clinical trials;\n* Those who are allergic to this product or other genetically engineered E. coli-derived biological products;\n* The patient has any myelodysplastic and other blood system diseases;\n* Patients who have received hematopoietic stem cell transplantation or organ transplantation;\n* The patient has a severe mental or neurological condition that affects informed consent and/or adverse reaction presentation or observation.'}, 'identificationModule': {'nctId': 'NCT03776604', 'briefTitle': 'PEG-rhG-CSF in Elderly Patients With Small Cell Lung Cancer Receiving Chemotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.'}, 'officialTitle': 'Multi-center, Open, One-arm Clinical Study Evaluating the Efficacy and Safety of Jinyouli (PEGylated Recombinant Human Granulocyte Stimulating Factor, PEG-rhG-CSF) in Preventing Neutropenia After Chemotherapy in Elderly Patients With Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'CSPC-JYL-SCLC-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEG-rhG-CSF', 'description': "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.\n\nDosing time: 48 h after chemotherapy.", 'interventionNames': ['Drug: PEG-rhG-CSF']}], 'interventions': [{'name': 'PEG-rhG-CSF', 'type': 'DRUG', 'description': "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.\n\nJin 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.\n\nDosing time: 48 h after chemotherapy.", 'armGroupLabels': ['PEG-rhG-CSF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun Zhao, PhD', 'role': 'CONTACT', 'email': 'ohjerry@163.com', 'phone': '86-010-88196456'}], 'facility': 'Bejing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jun Zhao, PhD', 'role': 'CONTACT', 'email': 'ohjerry@163.com', 'phone': '86-010-88196456'}, {'name': 'Hanxiao Chen', 'role': 'CONTACT', 'email': 'Hanxiao0628@163.com', 'phone': '18810526948'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Peking University Cancer Hospital & Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}