Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
70 participants
OBSERVATIONAL
2024-11-01
2027-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Responsible Party
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Du Juan
Chief Physician
Locations
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Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PC-Maintenance therapy
Identifier Type: -
Identifier Source: org_study_id
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