A Prospective Observational Cohort Study on Longitudinal Monitoring of ctDNA MRD in Neoadjuvant Therapy for Pancreatic Cancer

Launched by RUIJIN HOSPITAL · Jul 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to monitor pancreatic cancer treatment by looking at tiny pieces of tumor DNA in the blood, called circulating tumor DNA (ctDNA). The researchers want to see if checking these DNA markers during treatment can help predict how well surgery will go and if patients will live longer without the cancer coming back. They are especially focusing on people with pancreatic cancer that is either borderline removable by surgery, high-risk but still removable, or locally advanced (meaning the tumor has grown but hasn’t spread to distant parts of the body). The study will help doctors understand if regular blood tests during treatment can guide how long patients should receive therapy before surgery.

Adults between 18 and 75 years old with confirmed pancreatic cancer that fits specific stages are eligible, as long as they are considered fit enough for treatment by a medical team and have not had any previous cancer treatments. Participants will receive the usual treatment decided by their doctor and will have blood samples taken at set times to check the ctDNA levels. They will be followed for about 18 months to see how they do after treatment, including whether the cancer stays away and overall survival. This study is non-invasive, meaning it won’t change the treatment patients get, but it could provide important information to improve future care for pancreatic cancer patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Subjects meeting ALL of the following criteria will be enrolled:
• • 1. Age and Gender :Aged 18-75 years, regardless of gender.
• 2. Diagnosis and Disease Stage :
• Pathologically confirmed pancreatic cancer, meeting NCCN guideline criteria for:
• A. High-risk resectable (meeting ≥1 criterion):
• • 1. Luminal stenosis of the portal vein or superior mesenteric vein on imaging;
• • 2. Radiographic stage T≥3 or N≥1;
• • 3. Serum CA19-9 ≥1000 U/mL (after resolution of jaundice);
• • 4. Confirmed regional lymph node metastasis;
• • 5. Significant weight loss (\>10% baseline) or severe pain requiring opioids.
• B. Borderline resectable :
• • 1. Tumor involving the common hepatic artery without celiac axis contact;
• • 2. Tumor contact with SMA ≤180°.
• C. Locally advanced (unresectable):
• • 1. Tumor encasement (\>180°) of the SMA, celiac axis, or common hepatic artery;
• • 2. Unreconstructable involvement of SMV/portal vein;
• • 3. No distant metastasis.
• • 3. Treatment Suitability :Deemed suitable for neoadjuvant therapy after multidisciplinary team (MDT) discussion .
• • 4. Performance Status :ECOG (Eastern Cooperative Oncology Group) performance status ≤1 .
• • 5. Life Expectancy :Estimated survival ≥6 months.
• 6. Organ Function :No severe cardiac, hepatic, or renal dysfunction, including:
• • ALT/AST ≤3×ULN (upper limit of normal); Serum creatinine ≤1.5×ULN .
• • 7. Informed Consent :Signed written informed consent voluntarily provided.
• Exclusion Criteria:
• * Subjects meeting ANY of the following criteria will be excluded:
• • 1. Distant Metastasis Radiographically confirmed distant metastatic lesions.
• 2. 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.
• • 3. Concurrent Malignancy Diagnosis of other active malignancies.
• • 4. Pregnancy or Lactation Female subjects who are pregnant or breastfeeding.
• • 5. Drug Allergy Hypersensitivity to any agents in the guideline-recommended first-line neoadjuvant regimen .
• • 6. Transplantation History Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation .
• 7. 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