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MRD in PAAD Adjuvant Therapy

Chinese Academy of Medical Sciences & Peking Union Medical College logo

Chinese Academy of Medical Sciences & Peking Union Medical College

Status

Active, not recruiting

Conditions

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

Treatments

Drug: Three-drug chemotherapy group
Drug: two-drug chemotherapy group

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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    1. Patients clinically diagnosed with pancreatic cancer, staged I-III (AJCC V8.0), who are scheduled to undergo curative surgery.
    2. No restrictions on gender; age between 18 and 70 years.
    3. Eastern Cooperative Oncology Group (ECOG) performance status score: ≤2.
    4. Expected survival time of ≥3 months.
    5. 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.
    6. Voluntary participation in this clinical study, with an understanding of the study procedures and the ability to sign an informed consent form.

Exclusion criteria

  1. Patients who have had other malignancies within the five years prior to this study.
  2. Patients who have received any antitumor treatment within six months prior to enrollment.
  3. 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.

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

MRD postive
Sham Comparator group
Treatment:
Drug: Three-drug chemotherapy group
MRD negative
Active Comparator group
Treatment:
Drug: two-drug chemotherapy group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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