CtDNA-guided Maintenance Therapy in Pancreatic Cancer

Last updated: June 27, 2025
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pancreatic Disorders

Pancreatitis

Digestive System Neoplasms

Treatment

N/A

Clinical Study ID

NCT07054879
PC-Maintenance therapy
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years, male or female

  • Histologically or cytologically confirmed primary diagnosis of pancreatic ductaladenocarcinoma (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 willingto provide written informed consent

Exclusion

Exclusion Criteria:

  • Prior history of radiotherapy, chemotherapy or surgical treatment for pancreaticcancer

  • Concurrent severe organ dysfunction or hematologic disorders

  • Tumor involvement of celiac axis or superior mesenteric artery, locally advanceddisease, or presence of distant metastases

  • Poor general condition deemed unable to tolerate chemotherapy

  • History of other malignancies within past 5 years (except adequately treatedcarcinoma 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 Cinfection, HIV infection

  • Patient or guardian unable to comprehend study objectives and requirements

  • Any other condition that in the investigator's judgment would make the patientunsuitable for study participation

Study Design

Total Participants: 70
Study Start date:
November 01, 2024
Estimated Completion Date:
January 01, 2027

Connect with a study center

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu
    China

    Active - Recruiting

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