Pancreatic cancer
Conditions
Interventions
Capecitabine dose escalation:Irinotecan liposome + oxaliplatin + capecitabine
Irinotecan liposome: 50mg/m2, ivgtt, d1
Oxaliplatin: 60mg/m2, ivgtt, d1
Capecitabine: Start the exploration with a dose of 850mg/m2, preset three dose groups of 850mg/m2, 1000mg/m2, and 1150mg/m2, po, twice a day, d1-7
(YNMT)·
Dose expansion study:Preoperative:
Irinotecan liposome: 50mg/m2, ivgtt, d1
Oxaliplatin: 60mg/m2, ivgtt, d1
Capecitabine: PR2D, po, twice a day, d1-7
Each treatment cycle lasts for two weeks. It is recommended to treat for a total of 4 to 6 cycles (the treatment cycle can be extended until the surgical resection criteria are met, as determined by t
Every two weeks constitutes one treatment cycle, and a total of six cycles are treated.
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patient fully understood this study, voluntarily participated and signed the informed Consent Form (ICF); 2. Age range: 18-75 years old; 3. Patients with borderline resectable pancreatic cancer confirmed by pathology or histology (According to the 2022CSCO guidelines: ? The tumor has contact with the portal vein - superior mesenteric vein >180°, or the contact is =3 months; 9. Absolute neutrophil count (ANC) >=1.5×10^9/L, platelet count >=100×10^9/L and hemoglobin >=90 g/L (no blood transfusion, blood products, use of granulocyte colony-stimulating factor or other hematopoietic stimulating factors for correction within 14 days prior to the laboratory test); 10. Liver and kidney functions: Serum creatinine <=1.5 times the upper limit of the normal value; AST and ALT <=2.5 times the upper limit of the normal value (<=5 times the upper limit of the normal value for patients with liver invasion); Total bilirubin <=1.5 times the upper limit of the normal value (<=3 times the upper limit of the normal value for patients with liver invasion); 11. Women of childbearing age must undergo a pregnancy test (serum) within 7 days before enrollment, and the result must be negative. They must also be willing to use appropriate contraceptive methods during the trial and for 6 months after the last administration of the trial drug.
Exclusion criteria
Exclusion criteria: 1. Have hypersensitivity reactions to any research drug or its components; 2. Concurrent severe uncontrolled concurrent infections or other severe uncontrolled concomitant diseases, moderate or severe kidney injury; (Such as advanced infection, uncontrollable hypertension, diabetes, etc.) 3. 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, second-degree or third-degree atrioventricular block; c. Severe and uncontrolled arrhythmias that require drug treatment; d. New York College of Cardiology classification >= grade III; e. Cardiac ejection fraction (LVEF) is less than 50%; f. A history of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically severe pericardial disease, or electrocardiogram evidence of acute ischemic or active conduction system abnormalities within 6 months prior to recruitment. 4. Active hepatitis B and C infections (positive hepatitis B surface antigen and hepatitis B virus DNA exceeding 1x10^3 copies /mL; Hepatitis C virus RNA exceeds 1x10^3 copies /mL; 5. Human Immunodeficiency virus (HIV) infection (HIV antibody positive); 6. Have had or are currently concurrently suffering from other malignant tumors (except for effectively controlled non-melanoma basal cell carcinoma of the skin, carcinoma in situ of the breast/cervix, and other malignant tumors that have been effectively controlled without treatment in the past five years); 7 Those with other malignant tumors that require treatment; 8. The researchers determined that patients were not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The maximum tolerated dose of the 2-week capecitabine regimen in the irinotecan liposome + oxaliplatin + capecitabine regimen;Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Progression-free survival;R0 resection rate;Overall survival ; | — |
Countries
China
Contacts
Public ContactXiaodong Tian
Peking University First Hospital
Outcome results
None listed