Boarderline resectable pancreatic cancer
Conditions
Interventions
Control group:NALIRIFOX
Experimental group:NASOX
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old; 2. According to the NCCN Clinical Practice Guideline for pancreatic Cancer (2024.V1), the clinicopathological and imaging evaluation met the NCCN guideline definition of borderline resectable pancreatic cancer, investigator's assessment of potentially resectable locally advanced pancreatic cancer, and high-risk resectable pancreatic cancer. 3. The definition of borderline resectable includes: (1) No distant metastasis. (2) Arteries: 1) Pancreatic head/uncinate process: the tumor was in contact with the common hepatic artery and did not extend to the celiac artery or the bifurcation of the hepatic artery, which could be safely and completely resected and reconstructed; The contact between tumor and superior mesenteric artery was less than 180°. The tumor touches the aberrant artery (such as accessory right hepatic artery, alternative right hepatic artery, alternative common hepatic artery, or alternative/accessory artery origin), but it can be completely resected and safely reconstructed. 2) pancreatic head/uncinate process: tumor contact with celiac artery 180°, or contact =180° with irregular venous contour or venous thrombosis, there are suitable vessels at the proximal and distal end of the involved site for complete resection and reconstruction; The tumor contacted the inferior vena cava. The definition of high-risk resectable pancreatic cancer (meeting one of these criteria) : stenosis of the lumen of the portal vein or superior mesenteric vein on imaging; Imaging staging T>=3 or N>=1; Serum CA19-9>=1000U/ml (after jaundice relief); Regional lymph node metastasis was clear. Significant weight loss or severe pain. 4. At least one measurable lesion was used as the target lesion (according to RECISTv1.1 criteria); 5. Have not received any anti-tumor therapy (including radiotherapy, ablation, chemotherapy, targeted therapy, immunotherapy, etc.) and investigational drug treatment; 6. ECOG: 0-1; 7. Expected survival time >=3 months; 8. Good major organ function, that is, meeting the following criteria (without receiving any blood components, cell growth factors within 14 days before starting treatment) : (1) Neutrophil count >=1.5*10^9/L; Platelet >=80*10^9/L; Hemoglobin >=9g/dl; Serum albumin >=3g/dl; (2) Total bilirubin =50% 9. Women of reproductive age must have a negative blood pregnancy test within 3 days before starting treatment and be willing to use an appropriate method of contraception during the test and for 6 months after completion of treatment. For men, surgical sterilization or consent to use an appropriate method of contraception during the study and for 3 months after the end of treatment; 10. All subjects voluntarily participated in this study and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pancreatic cancer originating from non-ductal epithelium, including pancreatic neuroendocrine carcinoma, pancreatic acinar cell carcinoma, pancreatoblastoma, solid pseudopapillary tumor; 2. Patients with known central nervous system metastases; 3. Severe gastrointestinal dysfunction (bleeding, obstruction; > grade 2 inflammation; Grade 1 or greater diarrhea). 4. The presence of third-space effusion (e.g., massive pleural effusion) in addition to ascites that could not reach a stable state (no intervention after drainage tube removal) within 2 weeks before the start of treatment; 5. Patients with symptomatic ascites, requiring puncture or drainage, or patients with ascites drainage within the past 3 months (except those with small and controllable ascites on imaging, but without clinical symptoms); 6. Known interstitial lung disease, except interstitial changes on imaging; 7. Known peripheral neuropathy (CTCAE>= grade 3); 8. Known dihydropyrimidine dehydrogenase (low activity) or deficiency; 9. Severe infection (CTCAE > 2) occurred within 4 weeks before the initiation of treatment, such as severe pneumonia requiring hospitalization, bacteremia, and infectious complications; Signs and symptoms of infection requiring treatment with intravenous antibiotics within 2 weeks before the initiation of treatment (except for prophylactic antibiotics); 10. Received any of the following: (1) Concomitant medication containing a strong inhibitor/strong inducer of CYP3A4 or CYP2C8 or a strong inhibitor of UGT1A1 within 2 weeks before the initiation of treatment; (2) patients received radiotherapy within 2 weeks before treatment; (3) major surgery (e.g., thoracotomy, laparotomy, etc.) within 4 weeks before the initiation of treatment; (4) receiving any other investigational drug within 4 weeks before the initiation of treatment, unless it was an observational (noninterventional) clinical study or an interventional clinical study follow-up. 11. Abnormal coagulation function, bleeding tendency, or receiving thrombolytic or anticoagulant therapy. Prophylactic use of low-dose aspirin (<=100mg/ day), low-molecular-weight heparin (enoxaparin 40mg/ day and its equivalent dose of other low-molecular-weight heparin) was allowed. 12. Have uncontrolled cardiac symptoms or diseases, such as: (1) heart failure of NYHA2 or above; (2) unstable angina; (3) myocardial infarction within 6 months; (4) patients with clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 13. A malignant tumor other than pancreatic cancer within 5 years before the initiation of treatment, excluding adequately treated cervical carcinoma in situ, skin basal cell or squamous cell carcinoma; 14. Known to be allergic to irinotecan liposome II, other liposome products, oxaliplatin, 5-FU, leucovorin or any of the ingredients in the above products; 15. Active syphilis infection with known acquired immunodeficiency syndrome (AIDS) or HIV test positive; 15. 16. A definite previous history of a neurological or psychiatric disorder, including epilepsy or dementia; 17. According to the investigator's judgment, the subject has other factors that may lead to the forced termination of the study, such as non-compliance with the protocol, suffering from other serious diseases (including mental diseases) requiring combined treatment, serious abnormal laboratory test results of clinical significance, family or social factors, and conditions that may affect the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival, EFS; | — |
Countries
China
Contacts
Public ContactBaiyong Shen
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed