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CtDNA-guided Maintenance Therapy in Pancreatic Cancer


2024-11-01


2025-12-31


2027-01-01


70

Study Overview

CtDNA-guided Maintenance Therapy in Pancreatic Cancer

This study aims to conduct a large-scale prospective clinical trial to evaluate the efficacy and safety of capecitabine monotherapy as maintenance treatment following standard adjuvant chemotherapy (gemcitabine plus capecitabine) in patients with resectable pancreatic cancer, and to analyze whether ctDNA-MRD testing can guide the selection of postoperative maintenance therapy.

N/A

  • Pancreatic Cancer
    • PC-Maintenance therapy

    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

    2025-06-27  

    N/A  

    2025-06-27  

    2025-06-27  

    N/A  

    2025-07-08  

    2025-07-08  

    N/A  

    2025-06  

    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
    : Experiment Group

    Patients received 6 cycles of standard adjuvant chemotherapy (gemcitabine plus capecitabine), followed by capecitabine monotherapy as maintenance treatment based on the patient's clinical condition

    Primary Outcome MeasuresMeasure DescriptionTime Frame
    2-year DFS ratethe proportion of cancer patients who remain free of disease recurrence or death from any cause within 2 years after surgeryAt the timepoint of 2 years after surgery
    Secondary Outcome MeasuresMeasure DescriptionTime Frame

    Contacts and Locations

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

    Study Contact

    Name: Juan Du, professor

    Phone Number: +8613951826526

    Email: dujuanglyy@163.com

    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 years, male or female
    • Histologically or cytologically confirmed primary diagnosis of pancreatic ductal adenocarcinoma (PDAC)
    • No evidence of distant metastasis (M0)
    • Underwent R0 radical resection within 3 months prior to enrollment
    • ECOG performance status of 0-1
    • Life expectancy ≥3 months
    • Patient or legal guardian is able to understand the study requirements and willing to provide written informed consent

    • Exclusion Criteria:

    • Prior history of radiotherapy, chemotherapy or surgical treatment for pancreatic cancer
    • Concurrent severe organ dysfunction or hematologic disorders
    • Tumor involvement of celiac axis or superior mesenteric artery, locally advanced disease, or presence of distant metastases
    • Poor general condition deemed unable to tolerate chemotherapy
    • History of other malignancies within past 5 years (except adequately treated carcinoma in situ of cervix or basal cell carcinoma of skin)
    • Any severe or uncontrolled systemic disease that may affect risk/benefit assessment, including but not limited to: uncontrolled hypertension, active hepatitis B or C infection, HIV infection
    • Patient or guardian unable to comprehend study objectives and requirements
    • Any other condition that in the investigator's judgment would make the patient unsuitable for study participation

    Collaborators and Investigators

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

    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