Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06867146

MRD in PAAD Adjuvant Therapy

Our preliminary research has explored the detection efficacy of minimal residual disease (MRD) in pancreatic cancer. In patients with pancreatic cancer undergoing dual-agent adjuvant chemotherapy, the median recurrence-free survival (RFS) is approximately 13.9 months. Due to the high postoperative recurrence rate, short survival time, and intense systemic chemotherapy in pancreatic cancer patients, there is an urgent clinical need to more accurately identify which patients will benefit from adjuvant therapy. This study aims to evaluate the application value and guiding significance of peripheral blood MRD in the decision-making process for adjuvant treatment in patients with resected pancreatic cancer.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Here's the translated and polished version of your content:
  • Patients clinically diagnosed with pancreatic cancer, staged I-III (AJCC V8.0), who are scheduled to undergo curative surgery.
  • No restrictions on gender; age between 18 and 70 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status score: ≤2.
  • Expected survival time of ≥3 months.
  • Willingness to comply with the study protocol for testing, treatment, and follow-up; consent to provide necessary clinical, pathological, and follow-up data for the study; and agreement to use the research data for future studies and product development.
  • Voluntary participation in this clinical study, with an understanding of the study procedures and the ability to sign an informed consent form.

Exclusion criteria

  • Patients who have had other malignancies within the five years prior to this study.
  • Patients who have received any antitumor treatment within six months prior to enrollment.
  • Patients with concomitant diseases that, in the investigator's judgment, pose a serious risk to patient safety or could affect the patient's ability to complete the study (such as poorly controlled hypertension, severe diabetes, thyroid disorders, psychiatric disorders, etc.), or any other conditions deemed unsuitable for participation.

Treatment and study plan

Three-drug chemotherapy group

Drug

Three-drug chemotherapy group, mFOLFIRINOX, including 5-fluorouracil, leucovorin, oxaliplatin and irinotecan.

two-drug chemotherapy group

Drug

two-drug chemotherapy group, including gemcitabine-based combination regimens (predominately gemcitabine/nab-paclitaxel or gemcitabine/capecitabine)

Primary outcomes

  1. DFS

    Time frame: up to 18 months

    DFS refers to the length of time after treatment during which a patient remains free of any signs or symptoms of the disease. It is primarily used in cancer research to measure the effectiveness of treatments in preventing recurrence. Median follow-up time up to 18 months

Secondary outcomes

  1. OS

    Time frame: up to 18 months

    OS measures the length of time from either the diagnosis or the start of treatment to the death of the patient, regardless of cause. Median follow-up time up to 18 months.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

The Role of Molecular Residual Disease in the Treatment Strategy and Prognosis Prediction of Pancreatic Cancer Patients Undergoing Adjuvant Therapy

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 10, 2025
Registry last updated
Mar 10, 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.

Published trials that share one or more normalized conditions with this study.