pancreatic cancer
Conditions
Interventions
Case series:2 cycles of gemcitabine plus albumin-paclitaxel followed by 2 cycles of mFOLFIRINOX
Sponsors
Department of Abdominal Oncology, West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) pathologically confirmed locally advanced or advanced pancreatic cancer patient, unresectable, diagnosis with comprehensive judgment based on pathology and imaging (CT or MRI); 2) Aged 18 to 75 years old; 3) Estimated survival = 3 months; 4) ECOG PS score 0- 1; 5) At least one measurable tumor lesion: long diameter of leision = 10 mm and short diameter of lymph node = 15 mm by spiral CTthe largest diameter must be = 20 mm by normal CT or physical examination; 6) The results of liver and kidney function tests and blood tests within 1 week before enrollment must meet the following conditions: Neutrophils (ANC) = 1.5 × 10^9/L, Platelets (PLT) = 80 × 10^9/L, Hemoglobin ( HGB) = 80g/L; Serum creatinine (Cr) = 1.5 × upper limit of normal; total bilirubin (TBI) = 2.5 × upper limit of normal, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) = 2.5 × upper limit of normal; 7) If there are symptoms of abdominal pain, it should be stable before the first dose, and no need for analgesic drugs; 8) If sexually active, the patient must agree to use appropriate contraception approved by the investigator while taking study drug. In addition, male and female patients are advised to use contraception after the end of treatment as per the product characteristics summary or the prescribing information provided in the study manual; 9) Patients voluntarily participate the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Known severe hypersensitivity to any ingredient of the study drugs; 2. Patients with known brain metastases; 3. more than 6 weeks for the enrollment from Initial diagnosis; 4. prior systemic therapy against cancer (including chemotherapy, radiotherapy, surgery, or other investigational therapy); 5. Obvious coagulation disorders, active bleeding and bleeding tendency; 6. History of other malignancies within 5 years (Except for adequately treated basal cell carcinoma of the skin and carcinoma in situ of the cervix); 7. interstitial pneumonia or pulmonary fibrosis; 8. Uncontrolled pleural effusion or ascites; 9. Serious uncontrolled medical illness, acute infection, recent history of myocardial infarction (within 3 months); 10. pregnant or lactating women; 11. unsuitable for enrollment in the opinion of the investigator; 12. resectable pancreatic cancer defined by NCCN guidelines (2019 NCCN V 1).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival (PFS);overall survival (OS);safety;quality of life; | — |
Countries
China
Contacts
Public ContactDan Cao
West China Hospital, Sichuan University
Outcome results
None listed