Safety and Efficacy of NRT6008 in Patients With Unresectable Locally Advanced Pancreatic Cancer (LAPC)

Exclusion Criteria

• •1. Allergic to the investigational drug NRT6008 injection itself or any of its components;
• •2. Contraindications to any of the three optional systemic chemotherapy regimens in this study judged by investigators;
• •3. Previous anti-tumor treatments for pancreatic cancer, including but not limited to chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc. Except for discontinuation of traditional chinese medicine or herbal medicine for at least 7 days prior to the screening period;
• •4. Contraindications to anesthesia;
• •5. History of any other malignant tumors within 5 years before receiving investigational drug treatment, except for cases of cured non-melanoma skin cancer, cervical carcinoma in situ, or basal cell carcinoma of the skin, Stage I Grade 1 endometrial carcinoma, or thyroid cancer;
• •6. Presence or suspected presence of distant metastases according to imaging;
• •7. Pregnant or lactating females;
• •8. Participants assessed by the investigators to be at high risk or had difficulty in operation for EUS-FNI procedures;
• •9. Evidence of radiographic invasion into stomach, duodenum or peritoneum;
• •10. Participants with chronic diseases that are actively treated but not well controlled, such as primary hypertension, diabetes, etc.;
• •11. Within 6 months prior to the the first administration of chemotherapy, occurrence of acute pancreatitis, severe gastrointestinal bleeding, severe cardiovascular diseases (including but not limited to stroke, unstable angina), or occurrence of acute infections requiring systemic treatment within 2 weeks before the screening period;
• •12. Participated in other interventional clinical trials within 1 month prior to the first administration of chemotherapy;
• •13. Positive for human immunodeficiency virus (HIV) antibodies;
• •14. Positive for hepatitis B virus (HBV) surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb), HBV DNA testing required, participants with HBV-DNA levels below the lower limit of the reference range or \< 500 IU/mL will be eligible for inclusion in this study (use of antiviral drugs during the study period is required);
• •15. Positive for hepatitis C virus (HCV) antibodies, HCV RNA testing required, participants with negative HCV RNA results will be eligible for inclusion in this study;
• •16. Participants with syphilis infection or active tuberculosis;
• •17. Other reasons deemed unsuitable for participation in this trial by the investigators.