Pancreatic cancer
Conditions
Interventions
Experimental Group:Irinotecan hydrochloride liposome Injection (II) : The dosage is 60mg/m 2, administered intravenously for 90 minutes (+/-30 minutes), and doted on day 1.
Oxaliplatin for injection:
=1.25 - < 1.5m^2 40mg bid
Take 50mg twice a day, D1-D7.
Preventive administration can be selected according to clinical needs. Each treatment cycle lasts for 14 days.
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients must meet all of the following inclusion criteria to be enrolled in this trial: 1. Age between 18 and 75 years old, both male and female are acceptable. 2. Confirmed as pancreatic ductal adenocarcinoma (PDAC) by histology or cytology; 3. Clinical records show borderline resectable pancreatic cancer [According to the CSCO guidelines 2022 Edition, borderline resectable pancreatic cancer is defined as: Tumor contact with portal vein - superior mesenteric vein >180°, or contact =12 weeks; 8. The functions of vital organs meet the following requirements (no blood components, cell growth factors, leukocyte-raising drugs, platelet-raising drugs, anemia-correcting drugs, etc. are allowed to be used within 14 days prior to the first use of the study drug); a. Absolute neutrophil count (ANC) >=1.5×10^9/L; b. Platelet count >=85×10^9/L; c. Hemoglobin >=90g/L; d. Serum albumin >=30g/L; e. Total bilirubin 60mL/min; g. Activated partial thromboplastin time (APTT) and international normalized ratio (INR) <=1.5 × ULN (screening can be conducted for those using stable-dose anticoagulant therapy such as low-molecular-weight heparin or warfarin with INR within the expected therapeutic range of the anticoagulant); 9. Women of childbearing age must have a negative result of a pregnancy test (serum or urine) within 7 days before enrollment, and voluntarily adopt appropriate contraceptive methods during the observation period and within 8 weeks after the last administration of the study drug. For men, surgical sterilization should be performed or they should agree to use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of the study drug. 10. The subjects voluntarily joined this study and signed the informed consent form.
Exclusion criteria
Exclusion criteria: Patients with any of the following conditions are not eligible for this study: 1. Not meeting the above inclusion criteria; 2. Severe gastrointestinal dysfunction (with bleeding, inflammation, obstruction or diarrhea greater than grade 1); 3. There is grade 3 or 4 peripheral neuropathy; 4. There is uncontrollable pleural effusion, pericardial effusion or ascites that requires drainage; 5. Uncontrollable systemic infections (viruses, bacteria and fungi); 6. Those who have been allergic to irinotecan liposomes, other liposome products, oxaliplatin, 5-fluorouracil, calcium folinate or any of the above components in the past; 7. Underwent major surgery within 4 weeks prior to the first use of the study drug; 8. Enroll in another clinical study simultaneously, unless it is an observational (non-interventional) clinical study or a follow-up study of an interventional clinical study; 9. The subject has cardiovascular clinical symptoms or diseases that are not well controlled, including but not limited to: such as: (1) NYHA grade II or above heart failure; (2) Unstable angina pectoris; (3) Myocardial infarction has occurred within one year; 10. The subjects have active hepatitis B (HBV DNA >= 2000IU/mL or 104copies/mL), hepatitis C (positive hepatitis C antibody, or HCV-RNA higher than the detection limit of the analytical method); 11. Any other malignant tumor was diagnosed within 5 years prior to the first use of the study drug, except for malignant tumors with a low risk of metastasis and death (5-year survival rate > 90%), such as well-treated basal cell or squamous cell skin cancer or cervical carcinoma in situ. 12. If the researcher determines that the subject has other factors that may force them to terminate the study halfway, such as suffering from other serious diseases (including mental disorders) that require combined treatment, family or social factors that may affect the subject's safety or the collection of research data; 13. Other factors that the researcher deems unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;Rate of treatment benefit;R0/R1 resection rate;Overall Survival;Safety; | — |
Countries
China
Contacts
Public ContactAng Lv
Beiing Cancer Hospital
Outcome results
None listed