Evaluate the Clinical Feasibility of a Novel Neoantigen-Reactive CD8+ T Cell (NART) Detection Technology for Postoperative MRD Surveillance of Pancreatic Cancer

Launched by SHANGHAI ZHONGSHAN HOSPITAL · Apr 19, 2025

Keywords

ClinConnect Summary

This clinical trial is looking to see how well a new technology called Neoantigen-Reactive CD8+ T cell (NART) can detect minimal residual disease (MRD) in patients who have had surgery for pancreatic cancer. MRD refers to cancer cells that may remain in the body after surgery, which can potentially lead to a recurrence of the disease. The main goal of the study is to find out if this NART technology is sensitive and accurate enough to help monitor patients after their surgery.

To be eligible for this trial, participants must be over 18 years old and have pancreatic cancer that can be surgically removed. They will need to agree to donate tumor samples taken during surgery and participate in periodic blood tests and imaging scans as part of the study. The trial is not yet recruiting participants, but it is open to anyone who meets the necessary criteria and can provide informed consent. If you or a loved one are interested, you would be closely monitored to see how well this new detection method works in identifying any leftover cancer cells after surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • age \>18
• • Assessd as resectable PDAC before surgical procedure
• • Voluntary to donate tumor samples resected in curative surgery for PDAC
• • Voluntary to participate in the radiological evaluation, tests of serum tumor markers, and the collection of MRD samples according to the study protocol
• • ECOG state (PS) grades ≤ 2
• • Voluntary to sign informed consent and adhering to the requirements and limitations outlined by lCD and this protocol
• • Confimed as pancreatic ductal adenocarcinoma by pathology
• • RO or R1 resection
• • Clinically evalutated eligible for adjuvant therapy
• • Tumor tissue samples meet the requirements of whole exome sequencing (WES)
• Exclusion Criteria:
• • Preoperative imaging examinations show distant metastasis
• • Have received neoadjuvant therapy
• • Have any other active malignancy within 5 years before enrollment, or have any other indolent cancers that did not interfere with the primary cancer assessment in the study without prior approval from the research committee
• • With other physical or mental conditions that may increase the risk of study participation or (in the investigator's judgment) may make the subject ineligible for study participation, including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormalities
• • Have participated in other interventional or observational clinical studies