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The Significance and Indications of Surgery for Synchronous Liver Metastatic Pancreatic Cancer


2024-08-23


2026-04-30


2026-06-30


50

Study Overview

The Significance and Indications of Surgery for Synchronous Liver Metastatic Pancreatic Cancer

To explore the clinical characteristics of pancreatic cancer patients with liver metastases who can benefit from surgery, and to develop evaluation criteria for surgical indications, so as to provide basis for comprehensive treatment strategies for advanced pancreatic cancer patients.

Initial Systemic Treatment: Subjects who meet the inclusion criteria will first undergo systemic treatment. The primary treatment regimens will follow the NCCN guideline-recommended first-line chemotherapy options, including the AG regimen, FOLFIRINOX regimen, and the NALIRIFOX regimen. Periodic Assessments: Every 4 treatment cycles, laboratory tests (including blood routine, coagulation function, liver and kidney function, and tumor markers) and imaging studies (enhanced CT or MRI, with PET-CT if necessary) will be conducted. After 4-6 cycles, imaging and tumor marker assessments will be performed to evaluate the patient's disease status. A multidisciplinary discussion will determine if patients with a good response to systemic treatment are eligible for radical surgery. Treatment Adjustment and Surgical Intervention: For patients assessed as having disease progression during the first evaluation, the treatment plan will be adjusted, and assessments will be conducted every 2 cycles. Patients showing a good response may still be considered for radical surgery. For pancreatic lesions, surgical procedures such as pancreaticoduodenectomy or distal pancreatectomy with splenectomy will be performed based on the lesion's location, with total pancreatectomy considered if necessary. For liver lesions, the surgical approach will depend on the number, size, and location of the lesions. During surgery, tumor and adjacent tissue samples (approximately 100mg, the size of a soybean) will be collected for research purposes, provided it does not affect diagnosis. Postoperative discarded specimens (approximately 500mg) will also be collected and preserved. Postoperative Monitoring: Laboratory tests, including but not limited to blood routine, coagulation, liver, kidney, and pancreatic function, will be collected on postoperative days 1, 3, 5, 7, and 30. Adjuvant Treatment and Complication Monitoring: Postoperative adjuvant treatment will continue according to the original regimen. Any postoperative complications and adverse reactions during chemotherapy will be recorded. Trial Progress Tracking: The progress of each subject will be documented. If a subject withdraws or drops out, the reason and the date of the last medication will be recorded. Follow-Up: After the completion of treatment, patients will be followed up monthly until death.

  • Pancreatic Cancer
  • Liver Metastases
  • Surgery
  • Adjuvant Therapy
    • 2024-KY-385-2
    • MR-11-25-016581 (OTHER Identifier) (OTHER: National Health Security Information Platform Medical Research Registration and Filing Information System)

    Study Record Dates

    These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

    Study Registration Dates Results Reporting Dates Study Record Updates

    2025-03-02  

    N/A  

    2025-04-13  

    2025-03-06  

    N/A  

    2025-04-16  

    2025-03-12  

    N/A  

    2024-08  

    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    Design Details

    Primary Purpose:
    N/A


    Allocation:
    N/A


    Interventional Model:
    N/A


    Masking:
    N/A


    Arms and Interventions

    Participant Group/ArmIntervention/Treatment
    : retrospective

    Retrospectively collect cases of pancreatic cancer with synchronous liver metastasis treated and analyze the preliminary results.

    : foresight

    On the basis of retrospective studies, a prospective clinical study is conducted. Through the prospective study of the outcomes of systemic treatment for patients with pancreatic cancer liver metastasis and the clinical results of surgical treatment after

    Primary Outcome MeasuresMeasure DescriptionTime Frame
    OSOverall Survivalthrough study completion, an average of 2 year
    Secondary Outcome MeasuresMeasure DescriptionTime Frame
    RFSRecurrence free survivalthrough study completion, an average of 2 year

    Contacts and Locations

    This section provides the contact details for those conducting the study, and information on where this study is being conducted.

    Participation Criteria

    Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

    Ages Eligible for Study:
    ALL

    Sexes Eligible for Study:
    18 Years

    Accepts Healthy Volunteers:

      Inclusion Criteria:

    • Age 18-75 years old
    • Pancreatic cancer was diagnosed as pancreatic ductal adenocarcinoma by biopsy of primary/metastases
    • Physical Condition Score (ECOG)0-1
    • Simultaneous/prior discovery of liver metastases and primary lesions was defined as simultaneous liver metastases
    • Enhanced CT/MRI can detect liver metastases (if the diseases not detected by enhanced CT/MRI during screening are not included in the number calculation)
    • The patient's liver, kidney and bone marrow function is good

    • Exclusion Criteria:

    • The primary lesions of pancreatic cancer are acinar cell carcinoma of pancreas, neuroendocrine carcinoma of pancreas and other pathological types
    • there are other metastases outside the liver
    • Had other malignant tumors within 5 years
    • History of central nervous system disease, mental illness, unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious diseases
    • Active or chronic hepatitis B/C virus infection
    • Allergy to iodine, unable to perform enhanced imaging
    • Previous anti-tumor therapy for pancreatic cancer (surgery/ radiotherapy/ chemotherapy/ ablation/ targeted therapy/ immunotherapy)

    Collaborators and Investigators

    This is where you will find people and organizations involved with this study.

    • Peking University First Hospital
    • Chongqing General Hospital
    • Tongji Hospital
    • Zhejiang Provincial People's Hospital

    • : ,

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available