pancreatic cancer
Conditions
Interventions
Test group:NASOX (Irinotecan liposomes, oxaliplatin, and tigio)
Sponsors
Huazhong University of Science and Technology Tongji Medical College Affiliated Union Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The patient fully understands this study, voluntarily participates and signs an informed consent form (ICF); 2. Age = 18 years old; 3. Pathologically or histologically confirmed resectable pancreatic cancer patients (according to the 2023CSCO guidelines: ? tumors do not contact the portal vein superior mesenteric vein, or contact the portal vein superior mesenteric vein = 180 ° and the vein contour is normal. ? tumors do not contact the artery (celiac trunk, superior mesenteric artery or common hepatic artery)), with high-risk factors described in the Comprehensive Diagnosis and Treatment Guidelines for pancreatic cancer (2018 Edition) and the New Adjuvant Treatment Guidelines for pancreatic cancer in China (2020 Edition), including: a. High levels of serum CA19-9, with CA19-9>1000 U/ml; b. Larger primary pancreatic tumor, with a maximum diameter of>3.0 cm; c. The maximum diameter of regional lymph nodes is>1.0 cm; d. NRS score 7-10 points; e. The researcher judged a significant weight loss; 4. Critically resectable pancreatic cancer patients diagnosed pathologically or histologically (according to the 2023CSCO guidelines: ? The tumor contacts the portal vein superior mesenteric vein>180 °, or = 180 ° with irregular vein contour or venous thrombosis, but can be completely resected and safely reconstructed; the tumor contacts the inferior vena cava. ? (Pancreatic head/uncinate process tumor) The tumor contacts the common hepatic artery, but does not involve the celiac trunk artery or the start of left and right hepatic arteries, so it can be completely resected and safely reconstructed; Tumor contact with superior mesenteric artery = 180 °; Tumor contact with mutated arteries (such as the right accessory hepatic artery, replacing the right hepatic artery, replacing the common hepatic artery, etc.); Tumor contact with superior mesenteric artery (pancreatic body and tail tumor) = 180 °; Tumor contact with abdominal trunk artery = 180 °; 5. Has not undergone any form of anti-tumor treatment in the past; According to RECIST 1.1 standard, patients have at least one measurable target lesion; 7. Eastern Cancer Collaborative Group (ECOG) physical fitness score: 0-2 points; 8. Estimated survival time = 3 months; 9. Absolute neutrophil count (ANC) = 1.5 × 10 ^ 9/L, platelets = 100 × 10 ^ 9/L and hemoglobin = 90 g/L (no blood transfusion, blood products, use of granulocyte colony-stimulating factor or other hematopoietic stimulating factor correction within 14 days prior to laboratory examination); 10. Liver and kidney function: serum creatinine = 1.5 times the upper limit of normal value; AST and ALT = 2.5 times the upper limit of normal values (= 5 times the upper limit of normal values for patients with liver invasion); Total bilirubin = 1.5 times the upper limit of normal value (= 3 times the upper limit of normal value for patients with liver invasion); 11. Women of childbearing age must undergo a pregnancy test (serum) within 7 days before enrollment, with a negative result, and are willing to use appropriate contraception methods during the trial period and 6 months after the last administration of the investigational drug.
Exclusion criteria
Exclusion criteria: 1. Within the 4 weeks prior to enrollment, any form of anti-tumor treatment, including radiotherapy, chemotherapy, molecular targeted therapy, and immunotherapy, has been performed; 2. Has hypersensitivity to any investigational drug or its components; 3. Severe uncontrolled concurrent infections or other serious uncontrolled concomitant diseases, moderate or severe kidney injury; (such as progressive infection, uncontrollable hypertension, diabetes, etc.); 4. Heart function and disease meet one of the following conditions: a. Long QTc syndrome or QTc interval>480 ms; b. Complete left bundle branch block, II or III degree atrioventricular block; c. Severe and uncontrolled arrhythmias that require medication treatment; d. The New York College of Cardiology has a classification of = III; e. Cardiac ejection fraction (LVEF) below 50%; f. A history of myocardial infarction, unstable angina, severe unstable ventricular arrhythmias, or any other arrhythmias requiring treatment, a history of clinically severe pericardial disease, or evidence of acute ischemic or active conduction system abnormalities on electrocardiogram within the 6 months prior to recruitment. 5. Active infection of hepatitis B and hepatitis C (hepatitis B B virus surface antigen is positive and hepatitis B B virus DNA exceeds 1x103 copies/mL; hepatitis C virus RNA exceeds 1x103 copies/mL); 6. Human Immunodeficiency Virus (HIV) infection (HIV antibody positive); 7. Has previously or currently suffered from other malignant tumors (except for effectively controlled non melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ, and other malignant tumors that have not been treated and have been effectively controlled within the past five years); Pregnant and lactating women, as well as patients of childbearing age who are unwilling to take contraceptive measures; 9. Patients with other malignant tumors that require treatment; 10. The researchers determined that patients who are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical resection rate;R0 resection rate;OS;PFS; | — |
Countries
China
Contacts
Public ContactHeshui Wu
Huazhong University of Science and Technology Tongji Medical College Affiliated Union Hospital
Outcome results
None listed