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CtDNA-guided Maintenance Therapy in Pancreatic Cancer

CtDNA-guided Maintenance Therapy in Pancreatic Cancer

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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

Study details
    Pancreatic Cancer

NCT07054879

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

15 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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