ctDNA MRD-guided adjuvant therapy for resected pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial enrolls patients with resected pancreatic ductal adenocarcinoma who underwent R0 surgery and randomizes them 1:1 to ctDNA MRD-guided adjuvant therapy or standard guideline-directed adjuvant treatment. In the experimental arm, clinicians will use next-generation sequencing of plasma ctDNA in the 2–12 week postoperative MRD window to inform whether to intensify, continue, or modify 12-week cycles of physician-selected adjuvant chemotherapy, while the control arm receives non-ctDNA-driven standard care. Serial ctDNA measurements and clinical follow-up will track MRD clearance, recurrence-free intervals, and safety outcomes. The aim is to personalize adjuvant treatment decisions based on molecular residual disease rather than relying solely on clinicopathologic risk factors.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Capable of providing written informed consent (ICF) and able to understand and agree to comply with the study requirements and assessment schedule
* Male or female aged 18-75 years at the time of ICF signing.
* Histologically confirmed pancreatic ductal adenocarcinoma, Stage I-III, and has undergone R0 resection.
* Time between surgery and randomization ≤ 12 weeks.
* ECOG PS 0-2.
* Fully recovered from surgery and able to receive adjuvant chemotherapy.
* Availability of sufficient tumor tissue for MRD testing.
* Patients with reproductive potential (female patients: must have entered the study after the menstrual period and with a negative pregnancy test) must agree to use two medically acceptable methods of contraception (one used by the patient and one by their partner) during the study and for 4 months (for females) or 6 months (for males) after the last study treatment.

Exclusion Criteria:

* Other types of non-ductal pancreatic tumors, including neuroendocrine tumors or acinar cell carcinoma, cystadenocarcinoma, and ampullary carcinoma.
* Hepatic or renal dysfunction as follows, or if the investigator considers adjuvant chemotherapy to be clearly contraindicated: a) Moderate/severe renal impairment (GFR \< 30 ml/min) calculated using the Cockcroft-Gault equation. b) Absolute neutrophil count \< 1.5 × 10\^9/L. c) Platelet count \< 100 × 10\^9/L. d) Hemoglobin \< 90 g/L. e) Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) \> 2.5 × the upper limit of normal.
* Pregnant or breastfeeding women.
* Any serious or uncontrolled systemic disease, including uncontrolled hypertension, active bleeding, active infection (including hepatitis B, hepatitis C, HIV, etc.), which the investigator deems unsuitable for participation in the study or likely to affect compliance with the study protocol.
* Concurrent presence of another malignancy or a history of malignancy (except for adequately treated carcinoma in situ of the cervix, basal cell carcinoma, or squamous cell carcinoma of the skin)
* Other conditions that the investigator deems unsuitable for participation in the study.

Where it's running

• Ruijing Hospital
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Baiyong Shen, Dr
• Email: shenby@shsmu.edu.cn
• Phone: 008613901943778

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.