NALIRIFOX as Induction Therapy in LAPC

Exclusion Criteria

• •1. Known allergy or intolerance to the ingredients or excipients of this investigational product.
• •2. Any metastatic lesions.
• •3. Patients with unresolved acute or chronic infection
• •4. Other malignancies within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
• •5. Active hepatitis.
• •6. Patients with portal hypertension or cavernous transformation of the portal vein; patients with gastrointestinal bleeding caused by tumor involving the digestive tract; patients with intra-abdominal fistula or abscess due to tumor involvement of digestive tract; the tumor encircles the celiac trunk or SMA and causes significant vascular wall involvement (worm-like changes);
• •7. Presence of third space effusion that cannot be controlled by drainage or other means (e.g., moderate-large pleural effusion, moderate-large pericardial effusion, ascites); a small amount of pleural effusion or ascites that is not clinically symptomatic and does not require clinical intervention should be strictly controlled before enrollment.
• •8. Mental illness or mental disorder, poor compliance, unable to cooperate with treatment
• •9. Patients with severe organic diseases or major organ failure, such as decompensated heart and lung failure, which lead to intolerance to chemotherapy.
• •10. Abnormal coagulation (INR \> 1.5, APTT \> 1.5 ULN), bleeding tendency (e.g., active ulcer lesions in the stomach, occult blood in stool (+ +), melena and/or hematemesis within 3 months, hemoptysis) or near the location of the lesion to major vessels.
• •11. Patients with Grade I or higher coronary heart disease, arrhythmia (including QTc prolongation \> 450 ms in males and \> 470 ms in females), taking arrhythmic drugs, or associated underlying heart disease and cardiac insufficiency.
• •12. Patients with renal insufficiency, previous renal disease, and positive urine protein (urine protein test 2 + or more, or 24-hour urineprotein quantitation \> 1.0 g).
• •13. Organ transplant recipients.
• •14. There are drug addicts and other adverse drug addicts, long-term alcoholics and AIDS and other infectious diseases.
• •15. Long-term use of corticosteroids or immunosuppressants.
• •16. Those who have received vaccines (including live and live attenuated vaccines) within 4 weeks prior to enrollment, such as measles, mumps, rubella, varicella, yellow fever, rabies, BCG, and typhoid (oral) vaccines, etc., or who plan to be vaccinated during study dosing; Allowing all types of COVID-19 vaccines.
• •17. Subjects with active hepatitis B or hepatitis C (HBV DNA ≥ 1 × 104 copies or ≥ 2000 IU/mL regardless of drug control; hepatitis C infection, HCV RNA ≥ 15 IU/mL); or HIV antibody positive (testing is not required if there is no clinical evidence of possible HIV infection); or syphilis antibody (TPPA) positive.
• •18. Breast feeding, known pregnancy, positive serum pregnancy test or unwillingness to use a reliable method of birth control, during therapy and for 6 months following the last dose of nal-IRI. Females of Childbearing Potential must either agree to use and be able to take effective contraceptive birth control measures (Pearl Index \< 1) or agree to use effective contraception during treatment and for at least 7 months after last application of program treatment. Males with female partners of reproductive potential should use condoms during treatment and for 4 months after the last dose. A female subject is considered to be of childbearing potential unless she is age ≥ 50 years and naturally amenorrhoeic for ≥ 2 years, or unless she is surgically sterile. Males must agree not to father a child (including not donating sperm) during the course of the trial and for at least 6 months after last administration of study drugs.
• •19. In the opinion of the investigator, the subject is unable to complete the entire trial process or other circumstances that are not suitable for participation in this trial.