Pancreatic cancer
Conditions
Interventions
Experimental group:Irinotecan liposome injection II: 60mg/m2, intravenous infusion for 90min (± 15min), D1
S-1: 40mg/m2, bid, oral, D1-7
Oxaliplatin: 85mg/m2, intravenous infusion for 2h or according to the clinical practice of the research center, D1:Q2W, Four weeks was a study cycle, a total of six cycles
Adabelimab,:1200mg,The infusion time should be controlled between 30 and 60 minutes, and the infusion should be completed within 2 hours at most.
Q4W, 6 cycles in total.
The patients were given triple
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Each must meet the following criteria: 1. Age >= 18 years old, regardless of gender; 2. Preoperative imaging and postoperative pathology confirmed that it was resectable pancreatic cancer (originated from pancreatic ductal epithelium), and radical resection had been performed. Postoperative pathology confirmed that it was completely resected under the microscope [r0] or completely resected under the naked eye [r1] (completely resected under the naked eye [r1] (R0 resection was performed if there were no tumor cells above 1mm at the cutting edge, otherwise R1 resection was performed); 3. ECoG physical status score: 0-1; 4. Expected survival >= 6 months; 5. The patients recovered completely after operation, and the adjuvant treatment was planned to start within 3 to 12 weeks after operation; 6. The main organs function well, that is, they meet the following criteria (without receiving any blood components and cell growth factors within 14 days before treatment): (1) Neutrophils >= 2*109/l; leukocytes>=3.0*109/l; platelets>80*109/l; hemoglobin>9g/dl; Serum albumin>3g/dl; (2) Bile element = 50ml/min; (4) INR=50%; 7. Women of childbearing age must have a blood pregnancy test within 7 days before enrollment, and the result is negative, and are willing to take appropriate contraceptive methods during the test and within 6 months after the end of treatment. For men, they should be sterilized by surgery, or agree to use appropriate methods of contraception during the study period and within 3 months after the end of treatment; 8. Participants voluntarily joined the study and signed the informed consent form; 9. Good compliance, agreed to cooperate with survival follow-up.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will not be allowed to enter the study: 1. ampulla tumor or pancreatic cancer of non pancreatic ductal epithelium origin, including pancreatic neuroendocrine carcinoma, pancreatic acinar cell carcinoma, pancreatoblastoma, solid pseudopapillary tumor and other patients; 2. Distant metastasis (including malignant ascites in abdominal cavity and pleural cavity, peritoneal metastasis) or local recurrent pancreatic cancer lesions; 3. Incomplete resection under the naked eye (R2); 4. Have previously received any systemic anti-tumor therapy (including chemotherapy, targeted therapy, immunotherapy, etc.), radiotherapy and interventional therapy; 5. Patients with known BRCA1/2 or PALB2 mutations: 6. Severe gastrointestinal dysfunction within 2 weeks before enrollment (bleeding, obstruction: inflammation greater than grade 2: diarrhea greater than grade 1); 7. Patients who cannot swallow drugs normally or take less than 1/2 of food by mouth; 8. The third space effusion (such as a large amount of pleural effusion) that could not reach a stable state (without intervention after removal of the drainage tube) within 2 weeks before enrollment was allowed to be treated with chemotherapy (including drainage tube and nutrition tube); 9. Known peripheral neuropathy (CTCAE = 2); 10. Dihydropyrimidine dehydrogenase activity is known to be low or deficient; 11. Severe infection (CTCAE >level 2) occurred within 4 weeks before enrollment, such as severe pneumonia, bacteremia, infection complications requiring hospitalization; symptoms and signs of infection within 2 weeks before enrollment required intravenous antibiotics (except for the use of prophylactic antibiotics); 12. Abnormal coagulation function, bleeding tendency or undergoing thrombolytic or anticoagulant therapy. Allow the preventive use of low-dose aspirin (= 100mg/day), low-molecular-weight heparin (enoxaparin 40mg/day and other low-molecular-weight heparin at its equivalent dose); 13. Patients with clinical symptoms or diseases of the heart that are not well controlled, such as: (1) heart failure above NYHA grade 2; (2) unstable angina pectoris; (3) myocardial infarction within 6 months; (4) patients with clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 14. Patients with malignant tumors other than pancreatic cancer within 5 years before enrollment, except fully treated cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma of the skin; 15. People who are known to be allergic to irinotecan liposomes, other liposome products, teguol, irinotecan, oxaliplatin and any of the ingredients in the above products or have contraindications to the above drugs; 16. Patients with active hepatitis B (HBsAg positive and HBV DNA = 500U/ml or 2500 copies/ml), hepatitis C (HCV antibody positive and HCV RNA higher than the upper limit of normal), and active tuberculosis; 17. People who are known to have acquired immunodeficiency syndrome (AIDS) or HIV test positive and active syphilis infection; 18. Have a clear history of neurological or mental disorders, including epilepsy or dementia; 19. According to the judgment of the researcher, the subject has other factors that may lead to 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 values wit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-month disease-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;Disease-free survival rate;Ssafety; | — |
Countries
China
Contacts
Public ContactZhe Cao
Peking Union Medical College Hospital
Outcome results
None listed