A Cohort Study on ctDNA MRD in Neoadjuvant Therapy for Pancreatic Cancer
Recruiting · NCT07080021 · Observational (researchers observe without assigning treatment) · Lead sponsor: Ruijin Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The goal of this prospective observational study is to learn about the clinical utility of dynamic ctDNA-based Minimal Residual Disease (MRD) monitoring in patients with borderline resectable pancreatic cancer undergoing neoadjuvant therapy. The main questions it aims to answer are: 1. Does MRD negativity correlate with improved surgical outcomes (R0 resection rates) and long-term survival (Disease-Free Survival \[DFS\] / Overall Survival \[OS\])? 2. Can serial MRD status assessments guide optimal neoadjuvant therapy duration? Participants (n=119) will be adults aged 18-75 years with histologically confirmed pancreatic cancer meeting NCCN criteria for borderline resectable/high-risk resectable/locally advanced disease, deemed eligible for neoadjuvant therapy by a multidisciplinary team (MDT) and with ECOG performance status ≤1. Patients with distant metastasis, prior anticancer therapy, or concurrent malignancies are excluded. During 24-month study period (12-month recruitment + 12-month follow-up), enrolled subjects will: 1. Receive standard-of-care neoadjuvant therapy/surgery per physician's decision. 2. Undo serial blood draws for ctDNA-MRD testing at predefined timepoints. 2\. Be followed for DFS/OS outcomes for 18 months. This non-interventional study is conducted at Ruijin Hospital Pancreatic Surgery Department.
Who can take part
Inclusion criteria
- Subjects meeting ALL of the following criteria will be enrolled:
- Age and Gender :Aged 18-75 years, regardless of gender.
- Diagnosis and Disease Stage :
- Pathologically confirmed pancreatic cancer, meeting NCCN guideline criteria for:
- A. High-risk resectable (meeting ≥1 criterion):
- Luminal stenosis of the portal vein or superior mesenteric vein on imaging;
- Radiographic stage T≥3 or N≥1;
- Serum CA19-9 ≥1000 U/mL (after resolution of jaundice);
- Confirmed regional lymph node metastasis;
- Significant weight loss (\>10% baseline) or severe pain requiring opioids.
- B. Borderline resectable :
- Tumor involving the common hepatic artery without celiac axis contact;
- Tumor contact with SMA ≤180°.
- C. Locally advanced (unresectable):
- Tumor encasement (\>180°) of the SMA, celiac axis, or common hepatic artery;
- Unreconstructable involvement of SMV/portal vein;
- No distant metastasis.
- Treatment Suitability :Deemed suitable for neoadjuvant therapy after multidisciplinary team (MDT) discussion .
- Performance Status :ECOG (Eastern Cooperative Oncology Group) performance status ≤1 .
- Life Expectancy :Estimated survival ≥6 months.
- Organ Function :No severe cardiac, hepatic, or renal dysfunction, including:
- ALT/AST ≤3×ULN (upper limit of normal); Serum creatinine ≤1.5×ULN .
- Informed Consent :Signed written informed consent voluntarily provided.
Exclusion criteria
- Subjects meeting ANY of the following criteria will be excluded:
- Distant Metastasis Radiographically confirmed distant metastatic lesions.
- Prior Anti-Tumor Therapy History of any prior anti-tumor treatment, including:
- Systemic chemotherapy Radiotherapy Interventional therapy Immunotherapy Targeted therapy Anti-tumor traditional Chinese medicine therapy.
- Concurrent Malignancy Diagnosis of other active malignancies.
- Pregnancy or Lactation Female subjects who are pregnant or breastfeeding.
- Drug Allergy Hypersensitivity to any agents in the guideline-recommended first-line neoadjuvant regimen .
- Transplantation History Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation .
- Immunodeficiency Disorders Congenital or acquired immunodeficiency, including:
- Human Immunodeficiency Virus (HIV) infection;
- Active Hepatitis B :
- HBsAg-positive andHBV-DNA ≥10,000 copies/mL (≥2,000 IU/mL) at screening;
- Active Hepatitis C :
- HCV-Ab-positive andHCV-RNA positive at screening; Co-infection with HBV and HC
Where it is running
2 locations listed.
- Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine - Shanghai, China
- Ruijin hospital - Shanghai, China