pancreatic cancer
Conditions
Interventions
Group mFOLFIRNOX:Perform chemotherapy with mFOLFIRNOX
Group GEM & 5-FU:Perform chemotherapy with GEM and 5-FU
Group GEM & Abraxane: Perform chemotherapy with GEM and Abraxane
Sponsors
Shanghai Changzheng Hospital affiliated to Second Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Preoperative diagnosis of pancreatic ductal adenocarcinoma was confirmed based on clinical symptoms, imaging examinations, tumor markers and other auxiliary examinations or biopsy results; 2. According to the NCCN guideline (2016), the inclusion PDAC is borderline resectable pancreatic cancer via preoperative imaging examinations. Arterial status: Pancreatic head or uncinate process: solid tumor contact with common hepatic artery (CHA) without extension to celiac axis or hepatic artery bifurcation allowing for safe and complete resection and reconstruction; solid tumor contact with the SMA of =180 degree; solid tumor contact with variant arterial anatomy (ex: accessory right hepatic artery, replaced right hepatic artery, replaced CHA and the origin of replaced or accessory artery) and the presence and degree of tumor contact should be noted if present. Pancreatic body/tail: solid tumor contact with the celiac axis (CA) of =180 degree; solid tumor contact with the SMA of >180 degree without involvement of the aorta and with intact and uninvolved gastroduodenal artery. Venous status: solid tumor contact with the SMV or PV of >180 degree, contact of =180 degree with contour irregularity of the vein or thrombosis of the vein but with suitable vessel proximal and distal to the site of involvement allowing for safe and complete resection and vein reconstruction; solid tumor contact with the inferior vena cava(IVC). 3. Aged 18 to 75 years old male and felmale; 4. Performance status ECOG grade 0 to 2; 5. Without serious blood system, heart function, lung function abnormality and immune deficiency (refer to corresponding criterions respectively); 6. Participate in the study voluntarily and sign the informed consent; 7. Comply with the research follow-up and other program requirements.
Exclusion criteria
Exclusion criteria: 1. With other system malignant tumor; 2. Accept any form of anti-tumor treatment 5 weeks before grouping randomly, including intervention, ablation, radiotherapy, chemotherapy and molecular targeted therapy, etc.; 3. Using any cstudy drug in other clinical trials 5 weeks before grouping randomly; 4. With any central nervous system disease, mental disease, unstable angina, severe congestive heart failure, arrhythmia or other serious diseases which cannot be control; 5. With allergy history of clinical trial drugs or similar structure drugs; 6. Lactating or pregnant; 7. Any situation which could damage patient safety or the integrity of the data,including severe medical risk factors, medical conditions, and laboratory abnormalities; 8. Patients are unwilling or unable to comply with the program, or loss to follow-up for more than 1 course during treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Operation rate of each group; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate Operation rate of each group;Lymph node negative rate of each group;curative effect of each group;progression-free survival;overall survival;perioperative condition;Toxic side effects of chemotherapy drugs; | — |
Countries
China
Contacts
Public ContactShao Chenghao
Shanghai Changzheng Hospital
Outcome results
None listed