Pancreatic Cancer
Conditions
Interventions
experimental group:mFOLFIRINOX regimen chemotherapy combined with losartan
control group:mFOLFIRINOX regimen chemotherapy
Sponsors
the Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following enrollment criteria to be enrolled in the study: 1. volunteering to participate in the trial and signing the informed consent form, with full understanding of the trial content, process and possible adverse reactions; 2. male or female subjects aged 18 years or older (including 18 years); 3. ECOG score 0-1; 4. patients with pancreatic cancer diagnosed by histopathology and/or cytology and undergoing radical pancreatic cancer surgery who are assessed by the investigator to be suitable for treatment with chemotherapy with the mFOLFIRINOX regimen; 5. expected survival time >= 3 months; 6. adequate bone marrow and organ function with the following test results to be completed within 7 days prior to the first study treatment: - Routine blood tests (no transfusion or hematopoietic stimulating factor therapy within 14 days prior to the test): neutrophil count (ANC) >= 1.5 x 10^9/L (1,500/mm3), platelets >= 100 x 10^9/(100,000/mm^3), and hemoglobin (Hgb) >= 9.0 g/dL (90 g/L); - Liver function tests: alanine aminotransferase (ALT) and aliquot aminotransferase (AST) = 60 mL/min (using the Cockcroft-Gault formula); - Coagulation function tests: prothrombin time and partial thromboplastin time <= 1.5 x ULN; 7. the subject is willing to have no plans to have children (including sperm or egg donation) from the time of signing the information to 6 months after the last dose, and voluntarily uses effective contraception (non-pharmacological contraception for the duration of the trial); 8. the subject is able to communicate well with the investigator and complete the study according to the requirements of the trial protocol.
Exclusion criteria
Exclusion criteria: Persons with any of the following conditions will be excluded 1. other serious cardiovascular, hepatic, renal, gastrointestinal, neurologic, endocrine, respiratory, and psychiatric abnormalities or a history of such illnesses, and who, in the opinion of the study physician, are not suitable participants; 2. a history of severe allergy or significant hypersensitivity or atopic reaction to any of the drugs in the treatment regimen; 3. patients with a known UGT1A1*28 gene-pure mutation ((TA)7/(TA)7) or a UGT1A1*6 gene-pure mutation (AA) 4. those with severe renal impairment (creatinine clearance 450ms (males) or QTc > 470ms (females) on 12-lead ECG at rest; - Acute coronary syndrome, congestive heart failure (New York Heart Association (NYHA) Cardiac Class = II) within 6 months prior to first dose, - Aortic dissection, stroke, or other grade 3 or higher cardiovascular event within 6 months prior to first dose; - Left ventricular ejection fraction (LVEF) 400mL, except physiologic blood loss in females) within 90 days prior to the first dose; 14. those who have had the following anti-tumor treatments prior to the first dose: any radiotherapy or chemotherapy within 30 days, any traditional Chinese medicine with anti-tumor indication within 14 days, any small molecule targeted drug within 14 days or 5 half-lives (whichever is shorter); 15. who have received any other unlisted clinical investigational drug within 30 days prior to the first dose; 16. who have received a live or live attenuated vaccine within 30 days prior to the first dose, or who plan to do so during the study; 17. who cannot complete the study for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival, DFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;biomarker; | — |
Countries
China
Contacts
Public ContactRen He
the Affiliated Hospital of Qingdao University
Outcome results
None listed