Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-29 @ 3:58 AM
Study NCT ID:
NCT03815461
Status:
UNKNOWN
Last Update Posted:
2019-01-25
First Post:
2019-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nab-paclitaxel Combined With S-1 as Induction Therapy for Locally Advanced Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}, {'id': 'C079198', 'term': 'S 1 (combination)'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2023-10-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-24', 'studyFirstSubmitDate': '2019-01-23', 'studyFirstSubmitQcDate': '2019-01-23', 'lastUpdatePostDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS', 'timeFrame': 'up to 2.5 years'}], 'secondaryOutcomes': [{'measure': 'R0 resection rate', 'timeFrame': '6 months'}, {'measure': 'Overall survival rate', 'timeFrame': '2 years'}, {'measure': 'Overall survival', 'timeFrame': 'up to 2.5 years'}, {'measure': 'Adverse reaction rate', 'timeFrame': 'up to 2.5 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Locally Advanced Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'This single-arm, Phase II clinical trial is to evaluate the efficacy and safety of nab-paclitaxel plus S-1 in locally advanced pancreatic cancer who were borderline resectable or unresectable .', 'detailedDescription': "This single-arm, Phase II clinical trial is to evaluate the efficacy and safety of nab-paclitaxel plus S-1 in locally advanced pancreatic cancer who were borderline resectable or unresectable . Nab-paclitaxel was administered at 125mg/m2 intravenously on day 1 and 8, S-1 （80, 100, or 120 mg/d according to body-surface area on days 1 through 14 of a 21-day cycle for 4-6 cycles.\n\nDuring the study, if the subject's weight change was ≤10% from baseline, the dose was calculated based on the measured value at baseline. If the change was \\>10%, the body surface area of the subject should be recalculated and the dose administered should be adjusted. .\n\nStudy treatment period Borderline resectable: According to the results of imaging examination, MDT discussed to determine the surgical resectability and timing of surgery. The chemotherapy time was 4-6 cycles.\n\nUnresectable: Chemotherapy for up to 6 cycles. According to the results of imaging examination, MDT determined the resectability of the operation. It was decided by the investigator and the patient to continue chemotherapy (S-1 maintenance), surgery or radiotherapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient compliance is good, the research process of this study can be understood, and written informed consent is signed;\n* Age ≥ 18 years old, ≤ 75 years old;\n* Histologically or cytologically confirmed pancreatic adenocarcinoma；\n* no prior treatment;\n* Based on imaging findings, MDT decided patients intoborderline resectable (group A) or unresectable (group B) (according to the resectability assessment criteria in the 2018 Pancreatic Cancer Comprehensive Care Guidelines);\n* ECOG\\<2;\n* Bone marrow function: hemoglobin (HGB) ≥ 90g / L; absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; platelets (PLT) ≥ 100 × 109 / L;\n* Liver function: ALT, AST ≤ 2.5 × upper limit of normal (ULN), if there is liver metastasis, ALT, AST ≤ 5 × ULN; serum total bilirubin \\< 1.5 × ULN;\n* Renal function: serum creatinine is within normal range;\n* Patients without biliary obstruction, patients requiring biliary stent implantation must be completed at least 7 days prior to enrollment;\n* Non-pregnant and lactating women, women of reproductive age/male should take effective contraceptive measures during the study period and within 6 months after the end of the study treatment;\n* No contraindication to the use of S-1and albumin-bound paclitaxel.\n\nExclusion Criteria:\n\n* Patients who have had other malignant tumors within 5 years (except for cured cervical cancer in situ or non-melanoma skin cancer);\n* Interstitial pneumonia or pulmonary fibrosis;\n* Severe pleural effusion or ascites;\n* Watery diarrhea;\n* There are serious concomitant diseases: such as HIV-positive,chronic HBV/HCV in active period, people who have diabetes and poorly controlled by hypoglycemic drugs, clinically severe (ie, active) heart disease, uncontrolled epilepsy, central nervous system disease or mental disorder;\n* Current or previous patients with grade II peripheral neuropathy;\n* Abnormal digestive tract or metabolic function, which may affect the s-1 absorber;\n* Participated in other clinical researchers within 4 weeks prior to enrollment;\n* Patients who have undergone organ transplantation;\n* Patients considered by the investigator to be unfit for this trial.'}, 'identificationModule': {'nctId': 'NCT03815461', 'briefTitle': 'Nab-paclitaxel Combined With S-1 as Induction Therapy for Locally Advanced Pancreatic Cancer', 'organization': {'class': 'UNKNOWN', 'fullName': 'ChineseAMS'}, 'officialTitle': 'Phase II Clinical Study of Nab-paclitaxel Combined With S-1 as Induction Therapy for Locally Advanced Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'CSPC-KAL-PC-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experiment group', 'description': 'Nab-paclitaxel+S-1', 'interventionNames': ['Drug: Nab-paclitaxel and S-1']}], 'interventions': [{'name': 'Nab-paclitaxel and S-1', 'type': 'DRUG', 'description': 'Nab-paclitaxel was administered at 125mg/m2 intravenously on day 1 and 8, S-1 （80, 100, or 120 mg/d according to body-surface area on days 1 through 14 of a 21-day cycle for 4-6 cycles.', 'armGroupLabels': ['experiment group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Zhou Aiping', 'role': 'CONTACT', 'email': 'zhouap1825@126.com', 'phone': '+86 13691161998'}], 'facility': 'National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Zhou Aiping', 'role': 'CONTACT', 'email': 'zhouap1825@126.com', 'phone': '+86 13691161998'}, {'name': 'Zhou Aiping', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Zhou Aiping', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Center/Cancer Hospital, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cancer Hospital & Institute', 'investigatorFullName': 'Aiping Zhou', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences'}}}}