Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:31 AM
Study NCT ID:
NCT07326150
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-01-08
First Post:
2025-12-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Construction of a Predictive Model for the Efficacy of Chemoprevention Combined With Targeted Therapy in Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'D013048', 'term': 'Specimen Handling'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Patient tumor tissue sections, blood and fresh tumor tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-12-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-25', 'studyFirstSubmitDate': '2025-12-25', 'studyFirstSubmitQcDate': '2025-12-25', 'lastUpdatePostDateStruct': {'date': '2026-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Best Tumor Response', 'timeFrame': '12 months', 'description': 'Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.'}, {'measure': 'Overall Survival', 'timeFrame': '60 months', 'description': 'Overall survival is the duration from diagnosis to death. For patients who are alive, overall survival is censored at the last contact.'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival', 'timeFrame': '36 months', 'description': 'The period from diagnosis until disease progression or death on study, whichever occurred first.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chemotherapy combined with immunotherapy', 'efficacy prediction', 'Organoids', 'Pancreatic Cancer'], 'conditions': ['Pancreatic Cancer Resectable', 'Pancreatic Cancer Non-resectable']}, 'descriptionModule': {'briefSummary': 'This study is a single-center, observational clinical trial designed to enroll a total of 70 pancreatic cancer patients. Tumor tissue sections from 60 patients will be retrospectively collected to establish a treatment response prediction model using spatial transcriptomics and other analyses. Fresh tumor tissue and blood samples from 10 patients will be prospectively collected to establish pancreatic cancer organoids and humanized immunocompetent mouse models for functional validation and exploration of the underlying molecular mechanisms.', 'detailedDescription': 'Primary Objective: Based on a cohort of pancreatic cancer patients receiving combined chemotherapy with immunotherapy and targeted therapy, analyze tumor microenvironment characteristics through multiplex immunohistochemistry and spatial transcriptomics. Identify key biomarkers associated with treatment efficacy and prognosis, and establish a clinically applicable predictive model for treatment outcomes in pancreatic cancer patients undergoing combined chemotherapy with immunotherapy and targeted therapy.\n\nSecondary Objectives: Establish pancreatic cancer organoids and humanized immunocompetent mouse models to functionally validate the aforementioned efficacy prediction model and explore the molecular mechanisms by which the tumor microenvironment modulates treatment response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pancreatic cancer confirmed by pathology and imaging studies', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Pathologically and radiologically confirmed pancreatic cancer\n\nExclusion Criteria:\n\n* Active malignancy other than pancreatic malignancy within the past 5 years or concurrently'}, 'identificationModule': {'nctId': 'NCT07326150', 'briefTitle': 'Construction of a Predictive Model for the Efficacy of Chemoprevention Combined With Targeted Therapy in Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang Cancer Hospital'}, 'officialTitle': 'Construction of a Predictive Model for the Efficacy of Chemoprevention Combined With Targeted Therapy in Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'IRB-2025-1714（IIT）'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pancreatic ductal adenocarcinoma', 'description': 'Pancreatic cancer confirmed by pathology and imaging studies', 'interventionNames': ['Other: Sample Collection']}], 'interventions': [{'name': 'Sample Collection', 'type': 'OTHER', 'description': "1. Blood Sample Collection: Prior to initial treatment, collect one tube of clotting blood (10 ml, serum separator tube) from the patient.\n2. Fresh Tumor Tissue: With informed consent obtained, collect pancreatic cancer or liver metastatic tissue specimens (one 2cm³ surgical specimen or one ≥1cm biopsy specimen) via surgery or biopsy prior to treatment.\n3. Tumor Tissue Sections: Retrospectively collected from our hospital's pathology department, 60 pancreatic cancer patient samples archived over the past 5 years were retrieved.", 'armGroupLabels': ['Pancreatic ductal adenocarcinoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310022', 'city': 'Zhejiang', 'state': 'Hangzhou', 'country': 'China', 'facility': 'Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)', 'geoPoint': {'lat': 22.4143, 'lon': 108.78745}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'We currently have no plans to share individual participant data (IPD) with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang Cancer Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Ying Jieer', 'investigatorAffiliation': 'Zhejiang Cancer Hospital'}}}}