pancreatic cancer
Conditions
Interventions
Pancreatic cancer patients who are scheduled for adjuvant therapy after radical resection:HR070803+Oxaliplantin+5-FU/LV
Pancreatic cancer patients who are scheduled for adjuvant therapy after radical resection:Gemcitabine+Capecitabine
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18~75 years old (including 18 and 75 years old), regardless of gender; 2) Histopathologically confirmed pancreatic cancer (originating from the pancreatic ductal epithelium) has undergone radical resection, and postoperative pathology has confirmed complete resection under a microscope [R0] or complete resection under the naked eye [R1] (no resection margin more than 1 mm) Tumor cells are resected as R0; otherwise they are resected as R1); 3) ECOG (Eastern et al. Group) performance status score: 0~1 points; 4) Expected survival = six months; 5) Complete recovery after surgery; plan to start adjuvant treatment within three weeks to 12 weeks after surgery; 6) The main organs function well; that is, they meet the following standards (if they have not received any blood components or cell growth factors within 14 days before randomization): a) Neutrophils =2 ×109/L; b) White blood cells =3.0 ×109/L; c) Platelets =100 ×109/L; d) Hemoglobin =90 g/L; e) Total bilirubin =1.5×ULN; f) AST and ALT=2.5×ULN; g) Creatinine clearance =50 ml/min (see Appendix 7 for calculation formula) or serum creatinine =1.5×ULN; h) INR = 1.5×ULN and APTT = 1.5 i) Electrocardiogram: QTcF = 450ms (male), = 470ms (female) (see Appendix 7 for the calculation formula); j) Cardiac color ultrasound: LVEF (left ventricular ejection fraction) =50%. 7) Women of childbearing age must take a blood pregnancy test within three days before randomization, with a negative result, and be willing to take appropriate measures to avoid pregnancy during the trial and within six months after the end of treatment. Pregnant. For males, they should be surgically sterilized or agree to use appropriate methods of contraception during the study and within three months after the end of treatment; 8) Voluntarily participate in this study and sign the informed consent form; 9) Have good compliance and agree to cooperate in survival follow-up.
Exclusion criteria
Exclusion criteria: 1) Pancreatic cancer originating from non-pancreatic ductal epithelium, including patients with pancreatic neuroendocrine carcinoma, pancreatic acinar cell carcinoma, pancreatoblastoma, and solid-pseudopapillary tumors. 2) The presence of distant metastasis (including malignant abdominal and pleural effusion, peritoneal metastasis) or local recurrent pancreatic cancer lesions. 3) Incomplete resection to the naked eye (R2). 4) CA19-9>180 U/mL within 21 days before enrollment. 5) Patients with known BRCA1/2 or PALB2 mutations. 6) Have you received any systemic anti-tumor treatment (including chemotherapy, targeted therapy, immunotherapy, etc.), radiotherapy, or interventional therapy in the past? 7) Have received any other clinical research drug treatment within four weeks before randomization, unless it is an observational (non-interventional) clinical study or interventional clinical study follow-up. 8) Severe gastrointestinal dysfunction (bleeding, obstruction, inflammation greater than grade 2, diarrhea greater than grade 1). 9) Known interstitial lung disease, except for interstitial changes shown only on imaging. 10) Known peripheral neuropathy (CTC AE=Grade 2). 11) Dihydropyrimidine dehydrogenase activity is known to be low or lacking. 12) There is medium or sizeable third space effusion that cannot reach a stable state (no intervention is required after removal of the drainage tube) within two weeks before randomization. 13) Severe infection (CTC AE>2) occurred within four weeks before randomization, such as severe pneumonia, bacteremia, infectious complications, etc., that required hospitalization; symptoms and signs of infection within two weeks before randomization required intravenous use of Antibiotic treatment (except where prophylactic antibiotics are used). 14) Seriously abnormal coagulation function, bleeding tendency, or currently receiving thrombolytic or anticoagulant treatment. Prophylactic use of low-dose aspirin (=100 mg/day) and low-molecular-weight heparins (enoxaparin 40 mg/day and other low-molecular-weight heparins at equivalent doses) is allowed. 15) Have cardiac clinical symptoms or diseases that cannot be well controlled, including but not limited to: a) NYHA class 2 and above heart failure. b) Unstable angina. c) Myocardial infarction within six months. d) Patients with clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention. 16) Suffering from malignant tumors other than pancreatic cancer within five years before randomization, except for fully treated cervical carcinoma in situ, skin basal cell, or squamous epithelial cell carcinoma. 17) There are any contraindications to any of liposomal irinotecan, irinotecan, 5-FU, calcium leucovorin, oxaliplatin, capecitabine, and gemcitabine. 18) People are known to be allergic to liposomal irinotecan, other liposome products, oxaliplatin, 5-FU, calcium leucovorin, capecitabine, gemcitabine, and any ingredients in the above products. 19) Combined with active hepatitis B (positive hepatitis B surface antigen and HBV DNA =500IU/mL or 2500 copies/mL), hepatitis C (positive hepatitis C antibody, and HCVRNA higher than the upper limit of normal). 20) People who are known to have acquired immunodeficiency syndrome (AIDS), HIV-positive test, or active syphilis infection. 21) Have a clear history of neurological or mental disorders, including epilepsy or dementia. 22) Those planning to become pregnant, pregnant and lactating wom
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Free Survival;Effectiveness of postoperative adjuvant therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;3-year disease-free survival rate;3-year overall survival rate;5-year disease-free survival rate;5-year overall survival rate;Safety of postoperative adjuvant therapy;Health-related changes; | — |
Countries
China
Contacts
Public ContactYu Xianjun
Fudan University Shanghai Cancer Center
Outcome results
None listed