Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT04707118
Status:
UNKNOWN
Last Update Posted:
2021-01-13
First Post:
2021-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ntraperitoneal Thermal Perfusion Combined With Chemotherapy Versus Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 106}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-02-23', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-10', 'studyFirstSubmitDate': '2021-01-10', 'studyFirstSubmitQcDate': '2021-01-10', 'lastUpdatePostDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ascites control', 'timeFrame': '4 weeks', 'description': 'The change of abdominal volume of subjects from enrollment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': "In view of the existence of malignant ascites in patients with advanced pancreatic cancer, we put forward the heat abdominal cavity perfusion chemotherapy combined albumin paclitaxel and gemcitabine compared with albumin paclitaxel and gemcitabine prospective clinical study, to assess abdominal albumin hot perfusion chemotherapy combined control of ascites and taxol in improving patients' quality of life, survival, exploring the feasibility of celiac hot perfusion chemotherapy combined albumin paclitaxel and side effects."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participate voluntarily and sign informed consent;\n* Age ≥18 years old and ≤80 years old, regardless of gender;\n* Physical condition ECOG 0 \\~ 2;\n* The diagnosis of pancreatic adenocarcinoma was confirmed by pathology;\n* Peritoneal metastasis was confirmed by ascites cytology, or was pathologically confirmed by surgical exploration and biopsy;\n* Expected survival ≥3 months;\n* No serious abnormal blood system, heart and lung function and immune deficiency (refer to respective standards);\n* Blood routine indicators: white blood cell (WBC) ≥3 × 109/L;Absolute count of neutrophils (ANC) ≥1.5 × 109/L;Platelet (PLT) ≥100 × 109/L;Hemoglobin (Hgb) ≥9 g/dL;\n* Blood biochemical indexes: AST (SGOT) and ALT (SGPT) ≤2.5 × upper limit of normal value (ULN);Total bilirubin (TBIL) ≤ULN;Serum creatinine (CRE) ≤1.5 × ULN;\n* Coagulation function: Prothrombin time (PT), international standard ratio (INR) ≤1.5 × ULN;\n* Comply with the study visit plan and other program requirements.\n\nExclusion Criteria:\n\n* Accompanied by other systemic malignant tumors;\n* Received any form of anti-tumor therapy, including interventional chemoembolization, ablation, radiotherapy, chemotherapy, tumor palliative resection and molecular targeted therapy;\n* Used any other study drugs within 5 weeks before enrollment;\n* Central nervous system diseases, mental diseases, unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious diseases that cannot be controlled;\n* Uncontrolled infection, bleeding, pancreatic leakage, bile leakage, or other postoperative complications during baseline examination;Acute and chronic metabolic acidosis (including ketoacidosis and lactic acidosis) has not been corrected.\n* A history of allergy to study drugs or similar structured drugs;\n* Pregnant or lactating women;\n* Any conditions, including serious medical risk factors, medical conditions, and laboratory abnormalities, that may impair patient safety or the integrity of research data;\n* Intestinal obstruction, extensive adhesion in the peritoneal cavity, abdominal inflammation, etc.'}, 'identificationModule': {'nctId': 'NCT04707118', 'briefTitle': 'Ntraperitoneal Thermal Perfusion Combined With Chemotherapy Versus Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Peritoneal Perfusion Chemotherapy Combined With Gemcitabine and Albumin Binding Paclitaxel Versus Gemcitabine and Albumin Binding Paclitaxel in the Treatment of Advanced Pancreatic Cancer With Intraperitoneal Metastasis', 'orgStudyIdInfo': {'id': 'CSPAC-30'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thermal perfusion cisplatin+Nab-paclitaxel+GEM', 'description': 'Laparoscopic exploration + thermal perfusion cisplatin 40 mg/m2, Postoperative exploration D1, 8 Nab-paclitaxel 125 mg/m2, GEM 1000 mg/m2, D1, 8, 15 after the second thermal perfusion 4 weeks plan, 6 cycles', 'interventionNames': ['Drug: cisplatin+Nab-paclitaxel+GEM']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nab-paclitaxel+GEM', 'description': 'Nab-paclitaxel 125 mg/m2, GEM 1000 mg/m2, D1, 8, 15 4 weeks plan, 6 cycles', 'interventionNames': ['Drug: Nab-paclitaxel+GEM']}], 'interventions': [{'name': 'cisplatin+Nab-paclitaxel+GEM', 'type': 'DRUG', 'description': 'Laparoscopic exploration + thermal perfusion cisplatin 40 mg/m2, Postoperative exploration D1, 8 Nab-paclitaxel 125 mg/m2, GEM 1000 mg/m2, D1, 8, 15 after the second thermal perfusion 4 weeks plan, 6 cycles', 'armGroupLabels': ['Thermal perfusion cisplatin+Nab-paclitaxel+GEM']}, {'name': 'Nab-paclitaxel+GEM', 'type': 'DRUG', 'description': 'Nab-paclitaxel 125 mg/m2, GEM 1000 mg/m2, D1, 8, 15 4 weeks plan, 6 cycles', 'armGroupLabels': ['Nab-paclitaxel+GEM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Sahnghai', 'country': 'China', 'contacts': [{'name': 'Xianjun Yu, Phd', 'role': 'CONTACT'}], 'facility': 'Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'xianjun YU, PhD', 'role': 'CONTACT', 'email': 'yuxianjun@fudanpci.org', 'phone': '18019112906'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'President of Shanghai Pancreatic Cancer Institute', 'investigatorFullName': 'Xian-Jun Yu', 'investigatorAffiliation': 'Fudan University'}}}}