Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-31 @ 3:00 PM
Study NCT ID:
NCT05222204
Status:
COMPLETED
Last Update Posted:
2025-05-22
First Post:
2021-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DDP ip Combined With AG in PDAC With Peritoneal Metastasis
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007263', 'term': 'Infusions, Parenteral'}, {'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'two cohort: cohort A (first-line) and cohort B (post-line with malignant ascites )'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-18', 'studyFirstSubmitDate': '2021-09-14', 'studyFirstSubmitQcDate': '2022-02-02', 'lastUpdatePostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months', 'description': 'patients the time from enrollment to death from any cause'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreatic Neoplasm']}, 'descriptionModule': {'briefSummary': 'intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel in patients with pancreatic cancer with peritoneal metastasis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\ncohort A\n\nPatients should meet the following criteria before treatment to be included in the trial:\n\n1. Voluntarily participate and sign the informed consent;\n2. Age ≥18 years old and ≤75 years old, gender is not limited;\n3. ECOG score ≤2 points;\n4. Pathological diagnosis of pancreatic adenocarcinoma;\n5. Advanced pancreatic cancer with intra-abdominal metastasis in imaging assessment, or intra-operative intra-operative findings of intra-abdominal metastasis;\n6. The time from the end of adjuvant chemotherapy after surgery is more than 6 months, or they have not received any form of anti-tumor therapy before, including interventional chemoembolization, ablation, radiotherapy, chemotherapy, and molecular targeted therapy;\n7. No serious abnormal blood system, heart, lung function and immune deficiency (refer to their respective standards);\n8. Blood routine indicators: white blood cells ≥3 × 109/L; absolute neutrophil count ≥1.5 × 109/L; platelets ≥100 × 109/L; hemoglobin ≥9 g/dL;\n9. Blood biochemical indexes: AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal (ULN); total bilirubin (TBIL) ≤ ULN; serum creatinine (CRE) ≤ 1.5 × ULN;\n10. Coagulation function: prothrombin time (PT), international normalized ratio (INR) ≤ 1.5 × ULN;\n11. Able to comply with research visit plans and other protocol requirements.\n\ninclusion criteria (Cohort B)\n\nPatients should meet the following criteria before treatment to be included in the trial:\n\n1. Voluntarily participate and sign the informed consent;\n2. Age ≥18 years old and ≤75 years old, gender is not limited;\n3. ECOG score ≤2 points;\n4. Pathological diagnosis of pancreatic adenocarcinoma;\n5. malignant ascites with positive peritoneal cytology or Laparoscopic exploration processed.\n6. At least one systemic chemotherapy has been used;\n7. No serious abnormal blood system, heart, lung function and immune deficiency (refer to their respective standards);\n8. Blood routine indicators: white blood cells ≥3 × 109/L; absolute neutrophil count ≥1.5 × 109/L; platelets ≥100 × 109/L; hemoglobin ≥9 g/dL;\n9. Blood biochemical indexes: AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal (ULN); total bilirubin (TBIL) ≤ ULN; serum creatinine (CRE) ≤ 1.5 × ULN;\n10. Coagulation function: prothrombin time (PT), international normalized ratio (INR) ≤ 1.5 × ULN;\n11. Able to comply with research visit plans and other protocol requirements.\n\nExclusion Criteria:\n\nPatients were excluded from the study if they met any of the following criteria:\n\n1. Associated with other systemic malignant tumors;\n2. Single kidney, deformed kidney or poor renal compensation;\n3. Have used any other study drug within 7 days before chemotherapy;\n4. Patients with central nervous system disease, mental illness, unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious diseases that cannot be controlled;\n5. There is a history of allergy to the study drug or drugs of similar structure;\n6. Patients who are using and require long-term use of warfarin anticoagulation.'}, 'identificationModule': {'nctId': 'NCT05222204', 'briefTitle': 'DDP ip Combined With AG in PDAC With Peritoneal Metastasis', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Intraperitoneal (IP) Cisplatin Combined With Intravenous Gemcitabine + Nab-paclitaxel in Patients With Pancreatic Cancer With Peritoneal Metastasis', 'orgStudyIdInfo': {'id': 'CSPAC-38'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IP', 'description': 'intravenous AG+ IP cisplatin', 'interventionNames': ['Drug: intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel']}], 'interventions': [{'name': 'intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel', 'type': 'DRUG', 'description': 'intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel in patients with pancreatic cancer with peritoneal metastasis', 'armGroupLabels': ['IP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': 'intravenous Gemcitabine+ Nab-paclitaxel combined with IP cisplatin in patients with PDAC with peritoneal metastasis'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Xian-Jun Yu', 'investigatorAffiliation': 'Fudan University'}}}}