Carcinoma of the body and tail of the pancreas
Conditions
Interventions
Splenic artery perfusion group:Splenic arterial perfusion chemotherapy (NCCN guideline recommendation: AG or FOLFIRINOX), 3 weeks is a treatment cycle, 6 courses
Sponsors
Department of Biliary-Pancreatic Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patient age 18-75 years old; 2. Patients with locally advanced or oligometastasis of the liver (5 metastases, which can be removed by small=-scale surgery) who are not suitable for radical surgery confirmed by histopathology or cytology; 3. No history of chemotherapy or immunotherapy before enrollment; 4. ECOG score 0-1 within 1 week before enrollment; 5. Expected survival time is greater than 3 months; 6. Adequate liver, kidney, and blood function reserves: (1) WBC>=2.5×10^9/L (2) PT extension =60mL/min (calculated by Cockcroft-Gault formula) (7) Serum albumin >=3.0g/dL 7. Female subjects of childbearing age must have a serum pregnancy study within 14 days before the start of study treatment, with a negative result, and be willing to use a reliable method of contraception during the study and within 60 days after the last dose of study drug; 8. Male subjects whose partners are women of childbearing age should agree to use reliable methods of contraception during the study and within 120 days after the last dose of study drug; 9. Subjects voluntarily join this study, sign the informed consent form, have good compliance, and are willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Other active malignant tumors other than pancreatic cancer in pregnant and lactating women. Cured localized tumors, including basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, and carcinoma in situ of the breast, with the exception of carcinoma in situ of the breast; 2. Distant metastasis (excluding intrahepatic metastasis, hilar lymph node metastasis, pancreatic head and colon invasion); 3. Patients who have received other systemic treatments after surgery; 4. Biliary obstruction has not been resolved; 5. Significant cardiovascular and cerebrovascular disease (e.g., New York Heart Association Class II or worse heart disease, myocardial infarction, or cerebrovascular accident), unstable arrhythmia or angina, or LVEF (left ventricular ejection fraction) on cardiac ultrasound within 3 months prior to the start of study treatment 10mg prednisone/day) or any other form of immunosuppressive therapy. Subjects using inhaled or topical corticosteroids may be enrolled; 11. Known previous allergy to macromolecular protein preparations, or any drug ingredients or excipients of sintilimab and GEMOX; 12. Active infection, unexplained fever (>=38.5°C) or baseline white blood cell count > 15×10^9/L within three days prior to dosing; 13. Bone marrow suppression above grade III. (white blood cells less than 1.9×10^9/L, hemoglobin less than 79g/L, platelets less than 49×10^9/L); 14. Severe hepatic insufficiency, serum albumin less than 28g/L, or serum direct bilirubin greater than 50µmol/L; 15. Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive; 16. Use of strong CYP3A4/CYP2C1 inducers including rifampicin (and its analogues) and forsythia or strong CYP3A4/CYP2C19 inhibitors within 14 days before enrollment; 17. Vaccinated or about to receive a live vaccine within 30 days before chemotherapy administration; 18. History of psychotropic substance abuse, alcohol or drug abuse; 19. Other factors that may affect the safety of the subject or study compliance as judged by the investigator. If there is a history of drug abuse, alcohol abuse or drug abuse such as serious illness (including mental illness) that requires combined treatment, or other family or social factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate,ORR;Disease control rate,DCR;Overall survival ,OS;adverse events; | — |
Countries
China
Contacts
Public ContactHaoming Lin
Department of Biliary-Pancreatic Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Outcome results
None listed