Locally advanced pancreatic cancer
Conditions
Interventions
Test arm:Subjects will be treated with the NALIRIFOX regimen every 2 weeks in 4-weeks cycles Imaging of tumor lesions will be performed after the subject has completed the first 2 cycles of treatment,
Sponsors
Jiangsu Province Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age = 18 years old, = 70 years old, male or female; 2. Understand the objectives and benefits and risks of the clinical trial, voluntarily participate in and sign the informed consent form; 3. ECOG score 0-1; 4. The subject had histopathologically or cytologically confirmed type of pancreatic ductal adenocarcinoma; 5. Initial subjects with locally advanced pancreatic cancer who have not undergone resection of pancreatic tumor (except open exploration or internal drainage surgery), chemotherapy, targeted, or immunotherapy; 6. At least one measurable pancreatic lesion per RECIST 1.1 criteria; 7. Expected survival time >= 3 months; 8. Heart, lung, liver, kidney and other major organ functions are basically normal; 9. Hematology tests should meet the following criteria (no blood transfusion, no use of blood products, granulocyte colony-stimulating factor, or other hematopoietic growth factors within 7 days prior to hematology): (1) White blood cell count >= 3.0 × 10^9/L and neutrophil count >= 1.5 × 10^9/L. (2) Platelet count >= 100 × 10^9/L. (3) Hemoglobin >= 90 g/L. (4) If component blood transfusions (red blood cells, platelets, etc.) are received at screening, reexamination of hematology must be performed at 1-week intervals before further screening can be considered; 10. Blood chemistry tests should meet the following criteria: (1) Plasma total bilirubin =50 mL/min calculated by the Cockcroft-Gault formula (Cockcroft-Gault formula: male Ccr = [(140-age) × body weight (kg)]/[0.818 × Scr (µmol/L)] or Ccr = (140-age) × body weight (kg)/72 × Scr (mg/dl), and female Ccr calculated as male × 0.85); 11. The subject had no symptoms of cardiac insufficiency (NYHA functional class <= II) at baseline and had no obvious abnormalities or abnormalities in electrocardiograms that were not clinically significant; 12. Good compliance, voluntary compliance with this clinical trial protocol and follow-up by the investigator during the study; 13. Subjects of childbearing potential voluntarily take highly effective contraceptive measures in the trial; 14. Females must be non-lactating.
Exclusion criteria
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; subjects with other serious medical conditions; 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; 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical conversion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Progression-free survival;Event-free survival;Disease control rate;Duration of response;Time to progress;Clinical Benefit Rate;Safety; | — |
Countries
China
Contacts
Public ContactKuirong Jiang
Jiangsu Province Hospital
Outcome results
None listed