Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-01-07 @ 11:43 PM
Study NCT ID:
NCT06967233
Status:
COMPLETED
Last Update Posted:
2025-05-13
First Post:
2025-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimodal Managements for Metastatic 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 360}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-10', 'studyFirstSubmitDate': '2025-05-02', 'studyFirstSubmitQcDate': '2025-05-10', 'lastUpdatePostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'From the date of treatment initiation to the date of death or the last date of follow-up (up to 60 months)', 'description': 'Calculated from the date of treatment initiation to the date of death or the last date of follow-up'}], 'secondaryOutcomes': [{'measure': 'Progression free survival', 'timeFrame': 'From the date of treatment initiation to the date of disease progression or death, whichever occurred first (up to 60 months).', 'description': 'The duration between the date of treatment initiation and disease progression or death, whichever occurred first.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'Pancreatic ductal adenocarcinoma (PDAC) remains a challenging malignancy, with over 300,000 patients diagnosed annually worldwide. Patients with metastatic pancreatic cancer (MPC) are generally not considered appropriate for operative management because it would not improve their prognosis.\n\nDevelopments in modern surgery and systemic treatment over the past decade have substantially improved the oncological outcomes for patients with PDAC. The prognosis can be further improved by using novel combined regimens. Systemic treatment is advantageous as it allows biological selection of patients and control of systemic lesions in patients with PDAC with only hepatic metastases (Hep-MPC), which may increase the likelihood of radical tumor resection and improved survival. Therefore, there is a strong need to reassess the value of surgery in Hep-MPC.\n\nLocoregional liver-directed treatments (LLDTs) are safe and efficient methodologies and have thus become the standard of care for patients with metastatic colorectal cancer (MCC) with liver-only or liver-dominant metastases. LLDT therapies include local liver resection, radiofrequency ablation (RFA), hepatic artery infusion pump chemotherapy (HAIP), stereotactic body radiation therapy (SBRT), and selective internal radiation therapy with yttrium-90 embolization (Y90). These therapies have been reported to influence the overall survival (OS), progression-free survival (PFS), and conversion to resection in patients with metastatic colorectal cancer. However, the data on the survival outcomes of conversion surgery and the clinical application of LLDT in Hep-MPC are sparse. Therefore, it remains unclear what types of treatment, based on the survival benefit, might actually be the optimal approach for Hep-MPC after effective systemic treatment.\n\nThe present study aims to clarify the selection criteria of conversion surgery for Hep-MPC and explore the prognostic significance for its multimodal management, including surgical resection and/or LLDT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients were cytologically or histologically diagnosed with pancreatic cancer, as well as with the primary tumor and liver metastasis. The primary and metastatic lesions were determined using CT and MRI.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients aged ≥18 years (at diagnosis).\n* Cytologically or histologically confirmed pancreatic adenocarcinoma.\n* Synchronous liver metastatic disease (at diagnosis).\n* No evidence of extrahepatic metastases (at diagnosis.)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.\n* Eligible for multimodal treatment.\n\nExclusion Criteria:\n\n* Multi-organ metastatic pancreatic cancer.\n* Contraindications to surgical resection or systemic treatment.\n* Inability to participate in follow-up assessments.\n* History of other malignancies.\n* Refusal of treatment.'}, 'identificationModule': {'nctId': 'NCT06967233', 'briefTitle': 'Multimodal Managements for Metastatic Pancreatic Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Analysis of the Current Situation of Diagnosis and Treatment of Pancreatic Cancer: Multimodal Managements for Metastatic Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'Multimodal-MPC'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Multimodal treatment', 'type': 'OTHER', 'description': 'Surgical resection, locoregional liver-directed treatments and continuous systemic treatment in patients with liver metastatic pancreatic cancer'}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The first affiliated hospital, Zhejiang university school of medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'TingBo Liang', 'investigatorAffiliation': 'Zhejiang University'}}}}