A Single-Arm Investigator-Initiated Tria (IIT) Evaluating the Safety and Preliminary Efficacy of Autologous Drug-Loaded Neutrophils (NeuMed) in Patients With Unresectable Pancreatic Cancer

Summary

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.

Eligibility

Inclusion Criteria:

* 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
* EOCG score ≤ 2 and expected survival time ≥ 3 months
* Liver, kidney and bone marrow functions are basically normal

Exclusion Criteria:

* 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
* Patients who have received live vaccines within 30 days prior to enrollment
* Patients with no response to bone marrow mobilization
* Other patients deemed unsuitable for enrollment by the investigator

Conditions2

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