ctDNA MRD-guided adjuvant therapy for resected pancreatic cancer

Assessing the Impact of Ct-DNA MRD-Guided Adjuvant Therapy on Outcomes in Resectable Pancreatic Cancer

This will test whether using circulating tumor DNA (ctDNA) minimal residual disease (MRD) to guide post-surgery chemotherapy helps patients with resected pancreatic ductal adenocarcinoma.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 856 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Ruijin Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai)
• Trial ID: NCT06966440 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–75 years with histologically confirmed resectable pancreatic ductal adenocarcinoma (Stage I–III) who had R0 resection within 12 weeks, ECOG 0–2, recovered from surgery, and have sufficient tumor tissue for MRD testing.

Not a fit: Patients with non-ductal pancreatic tumors, metastatic or unresectable disease, positive surgical margins (R1/R2), poor performance status, or inability to provide tumor tissue or attend serial blood draws are unlikely to benefit from this MRD-guided approach.

Why it matters

Potential benefit: If successful, this approach could reduce early recurrence by intensifying treatment for ctDNA-positive patients and avoid unnecessary chemotherapy for ctDNA-negative patients.

How similar studies have performed: Observational studies and early translational work, including prior analyses like NCT05479708, show ctDNA MRD strongly predicts recurrence and that MRD clearance correlates with lower relapse risk, but randomized MRD-guided adjuvant treatment strategies are still relatively novel.

Eligibility criteria

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 this trial is running

Shanghai

• Ruijing Hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Baiyong Shen, Dr

Conditions Pancreatic Adenocarcinoma Resectable