The goal of this clinical trial is to learn if Autologous Drug-Loaded Neutrophils (NeuMed) can treat patients with Unresectable Pancreatic Cancer. The drug carried by the Autologous Neutrophils is Monomethyl Auristatin E. The main questions it aims to answer are: First, to verify the safety of Autologous Drug-Loaded Neutrophils (NeuMed) in patients with Unresectable Pancreatic Cancer. Second, to assess the anti-tumor efficacy of Autologous Drug-Loaded Neutrophils (NeuMed) in patients with Unresectable Pancreatic Cancer.
18-70 years
Obtain an informed consent form voluntarily signed by the patient themselves
patients with Unresectable Pancreatic Cancer confirmed by Histopathology
Patients who either: 1) have received standard first-line treatments, proven ineffective or causing intolerable adverse effects; or 2) have not received the standard first-line treatments and voluntarily opt for Autologous Drug-Loaded Neutrophils (NeuMed)-based therapy
Patients who required anti coagulant therapy
Patients with active infectious diseases or a history of bone marrow or organ transplantation
Patients with autoimmune diseases or autoinflammatory diseases
Patients with a history of severe cardiovascular or cerebrovascular diseases or interstitial lung disease or non-infectious pneumonia
Single group
Monomethyl Auristatin E (MMAE) / autologous neutrophil biological agents
Combination productIsolate the patients' autologous neutriphil cells, induce and culture them with Monomethyl Auristatin E (MMAE) in a GMP-compliant laboratory. Prior to the reinfusion of neutrophil biological agents into patients, stereotactic radiotherapy with a dose of 2-6 Gy is administered to pancreatic cancer lesions. The number of neutrophils that were reinfused was 2.0-8.0x10\^8.
To verify the safety of Autologous Drug-Loaded Neutrophils (NeuMed) in patients with Unresectable Pancreatic Cancer
Incidence rate of Adverse Events（For the grading of treatment-related adverse events, all cases were classified with reference to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)）. Developed by the National Cancer Institute (NCI), the Common Terminology Criteria for Adverse Events (CTCAE) is currently the most widely used adverse event (AE) grading system, applicable to oncology clinical trials. It classifies adverse events into 5 grades:Grade 1 (Mild): Asymptomatic or mild in severity, with no requirement for intervention;Grade 2 (Moderate): Requiring medical intervention and causing mild impairment of daily activities;Grade 3 (Severe): Resulting in significant functional impairment, necessitating hospitalization or substantial medical intervention, and rendering the patient unable to perform daily activities;Grade 4 (Life-threatening): Pose a threat to life and require urgent intervention;Grade 5 (Death): Directly caused by the adverse event.
To assess the anti-tumor efficacy of Autologous Drug-Loaded Neutrophils (NeuMed) in patients with Unresectable Pancreatic Cancer
Objective Response Rate (ORR)；The ORR is determined by measuring the size of target and non-target tumor lesions in follow-up imaging data, in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST). The Response Evaluation Criteria in Solid Tumors (RECIST) classifies tumor response to treatment into distinct categories based on changes in the size of target lesions (and non-target lesions, as applicable) and the presence of new lesions, with the following specific grading framework:Complete Response (CR)；Partial Response (PR)；Stable Disease (SD)；Progressive Disease (PD). Imaging modalities for lesion measurement (e.g., contrast-enhanced CT, MRI) must be consistent throughout follow-up to ensure the reliability of SLD calculations, as mandated by the specific grading criteria in RECIST.
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