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NCT Number: NCT07054879

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 2-year DFS rate

    Time frame: At the timepoint of 2 years after surgery

    the proportion of cancer patients who remain free of disease recurrence or death from any cause within 2 years after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Juan Du, professor

CONTACT

[email protected]

+8613951826526

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Official study title

A Prospective Single-center Observational Study: ctDNA-guided Maintenance Therapy for Postoperative Pancreatic Cancer

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Jul 8, 2025
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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