Ignite Creation Date:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2025-12-31 @ 10:59 PM
Study NCT ID:
NCT04518800
Status:
UNKNOWN
Last Update Posted:
2020-08-19
First Post:
2020-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PEG-rhG-CSF in Secondary Prevention of Nab-Paclitaxel Combined With S-1 in Advanced Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-08-18', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2022-02-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-17', 'studyFirstSubmitDate': '2020-08-17', 'studyFirstSubmitQcDate': '2020-08-17', 'lastUpdatePostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of degree 3-4 neutropenia in each cycle of chemotherapy', 'timeFrame': 'last 4 cycles(each cycle is 21 days)', 'description': 'Incidence of degree 3-4 neutropenia in each cycle of chemotherapy'}], 'secondaryOutcomes': [{'measure': 'The incidence of febrile neutropenia in each cycle of chemotherapy', 'timeFrame': 'last 4 cycles(each cycle is 21 days)', 'description': 'Febrile neutropenia (FN) is defined as oral temperature \\>38.3℃ or continuous measurement of oral temperature \\>38.1℃ in 1h, with ANC \\<0.5×10\\^9/L or expected to be \\<0.5×10\\^9/L'}, {'measure': 'Incidence of chemotherapy dose adjustment due to neutropenia in each cycle of chemotherapy', 'timeFrame': 'last 4 cycles(each cycle is 21 days)', 'description': 'Incidence of chemotherapy dose adjustment due to neutropenia in each cycle of chemotherapy'}, {'measure': 'The proportion of patients hospitalized due to neutropenia', 'timeFrame': 'last 4 cycles(each cycle is 21 days)', 'description': 'The proportion of patients hospitalized due to neutropenia'}, {'measure': 'The proportion of patients receiving antibiotics during the entire chemotherapy period.', 'timeFrame': 'last 4 cycles(each cycle is 21 days)', 'description': 'The proportion of patients receiving antibiotics during the entire chemotherapy period.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PEG-rhG-CSF', 'Secondary Prevention', 'Pancreatic Cancer'], 'conditions': ['PEG-rhG-CSF', 'Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'A prospective, open, single-arm clinical study to evaluate the efficacy and safety of jinyouli（PEG-rhG-CSF） in the first-line treatment of advanced pancreatic cancer with nab-paclitaxel combined with S-1.Chemotherapy regimen: (1) chemotherapy: nab-paclitaxel, 260mg/m2, intravenous infusion for 30 minutes, D1, Q3W. S-1, 80-120mg, PO BID, D1-14, Q3W. (2) patients who met the eligibility criteria were given jinyouli injections 24 hours after the end of intravenous infusion of nab-paclitaxel during the treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years, ≤70 years;\n* Patients with Advanced Pancreatic Cancer diagnosed by histopathology，the expected survival time is more than 3 months;\n* Neutropenia of ≥2 degree occurred with the nab-paclitaxel + S-1 regimen in the previous cycle.\n* KPS score≥70;\n* The peripheral blood routine of the patients was normal: ANC ≥ 2.0x10\\^9/L, platelet count ≥ 90x10\\^9/L, HB ≥ 80g/L before enrollment, and there was no bleeding tendency;\n* Patients volunteered to participate in the trial, signed a written informed consent, willing to be followed up.\n\nExclusion Criteria:\n\n* There are uncontrollable infections at the moment or systemic antibiotic treatment within 72 h of chemotherapy；\n* Any abnormal bone marrow hyperplasia and other abnormal hematopoietic function；\n* Patients who had received bone marrow or hematopoietic stem cell transplantation within 3 months；\n* Patients with other malignancies that have not been cured or with brain metastases；\n* Total bilirubin(TBIL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\>2.5 ULN, or \\>5 ULN if there is liver metastasis;\n* Serum creatinine (Cr) exceeded the upper limit of normal value；\n* Allergic to this product or other biological products derived from genetically engineered escherichia coli；\n* Suffering from a mental or nervous system disorder, without self-awareness or coordination；\n* Patients expected to have a short survival or have difficulty tolerating chemotherapy；\n* Pregnant or lactating female patients；\n* Patients using other drugs of the same category or in clinical trials of other drugs；\n* Not suitable for participation at investigators' discretion."}, 'identificationModule': {'nctId': 'NCT04518800', 'briefTitle': 'PEG-rhG-CSF in Secondary Prevention of Nab-Paclitaxel Combined With S-1 in Advanced Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Prospective, Open, Single-arm Clinical Study Evaluating the Efficacy and Safety of PEG-rhG-CSF in Secondary Prevention of Nab-Paclitaxel Combined With S-1 in the First-line Treatment of Advanced Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'CSPC-JYL-PC-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Jin Youli(PEG-rhG-CSF)', 'description': 'PEG-rhG-CSF Secondary Prevention：patients with pancreatic cancer who met the eligibility criteria were given secondary prophylactic administration of the Jin Youli(PEG-rhG-CSF).', 'interventionNames': ['Drug: Jin Youli(PEG-rhG-CSF)']}], 'interventions': [{'name': 'Jin Youli(PEG-rhG-CSF)', 'type': 'DRUG', 'description': 'Jin Youli(PEG-rhG-CSF) was given 24 hours after the completion of intravenous infusion of albumin paclitaxel during the treatment period, 6 mg was given to patients with body weight ≥45 kg, and 3 mg was given for body weight \\<45 kg. Inject once every chemotherapy cycle', 'armGroupLabels': ['Jin Youli(PEG-rhG-CSF)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Guanghai Dai, PhD.', 'role': 'CONTACT', 'email': 'daigh301@vip.sina.com', 'phone': '13801232381'}], 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Guanghai Dai, PhD.', 'role': 'CONTACT', 'email': 'daigh60@sohu.com', 'phone': '13801232381'}], 'overallOfficials': [{'name': 'Guanghai Dai, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese PLA General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and chief physician', 'investigatorFullName': 'Dai, Guanghai', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}