Pancreatic cancer
Conditions
Interventions
Irinotecan liposome (II) combined with S-1 group:Irinotecan liposome (II) : 60 mg/m2, IV infusion, D1.
S-1: The initial dose (40-60mg/ time) was determined according to the body surface area, bid, ora
Sponsors
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Persons aged from 18 to 75 years old (on the day of signing the informed consent form) and voluntarily signing the informed consent form; 2. Pancreatic ductal adenocarcinoma (including adenosquamous carcinoma) confirmed by histology; 3. Resectable pancreatic cancer; 4. Fully recovered from surgery at study entry and able to start treatment within 12 weeks after surgery; 5. ECOG PS score 0-1; 6. Good organ function (no blood transfusion or growth factor support therapy within 2 weeks before blood sampling), including: (1) absolute neutrophil count (ANC)>=2×10^9/L; (2) hemoglobin (Hb) >=100 g/L; (3) platelet >=100×10^9 /L; (4) albumin >=30g/L; (5) Creatinine =50ml/min (Cockcroft-Gault formula); (6) Total bilirubin <=1.5 × ULN; (7) alanine aminotransferase (AST) and aspartate aminotransferase (ALT) <=3 times the upper limit of normal; (8) Coagulation function: prothrombin time (PT), international normalized ratio (INR) <=1.5×ULN. 7. Eligible individuals (men and women) of childbearing potential had to agree to use a reliable method of contraception (hormonal contraceptives, barrier methods, or abstinence) with their partner during the trial and for at least 6 months after the last dose. Individual women of reproductive age had to have a negative blood pregnancy test within 7 days before enrollment. 8. All subjects had no symptoms of cardiac dysfunction (NYHA class <=II) and no significant or clinically insignificant ECG abnormalities at baseline; 9. All subjects voluntarily participated in this study and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Subjects with pancreatic cancer arising from non-ductal epithelium, including pancreatic neuroendocrine carcinoma, pancreatic acinar cell carcinoma, pancreatoblastoma, solid/pseudopapillary tumor; 2. Prior neoadjuvant therapy, radiotherapy, or systemic therapy (including but not limited to systemic chemotherapy, molecular targeted therapy, immunotherapy, etc.) for pancreatic cancer; 3. Use of any Chinese herbal medicine or patent Chinese medicine with anti-cancer activity approved by the National Medical Products Administration (regardless of cancer type) within 14 days before the start of the study; 4. Present or past history of metastatic or locally recurrent pancreatic cancer (such as malignant ascites); 5. Postoperative serum CA 19-9 level > 180 U/ml within 21 days before the start of the study; 6. Have a history of allergy or hypersensitivity reactions to any study drug or its excipients, or exhibit any of the events outlined in the "contraindications or special warnings and Precautions" section of the prescribing information for this product, combination drug, or control drug; 7. Subjects with partial or complete intestinal obstruction or complete biliary obstruction that could not be relieved by active treatment; 8. Patients with a history of arterial or venous thrombosis (e.g., cerebral infarction, myocardial infarction, venous thrombosis of the lower extremity, arterial embolism of the lower extremity, pulmonary embolism, etc.) within 6 months before the start of the study but with stable thrombosis without cardiovascular risk as judged by the investigator could be enrolled; Subjects with evidence or history of bleeding tendency, regardless of severity, within 2 months before study initiation; 9. The presence of active malignant tumor within 5 years before the study, excluding pancreatic cancer studied in this trial and any locally curable tumor that has received curative treatment (e.g., resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast cancer in situ, and so on); 10. HBsAg positive and HBV-DNA higher than measurable lower limit or 1000 copies /mL (500 IU/mL) (whichever is lower), HCV antibody positive and HCV-RNA higher than measurable lower limit or 1000 copies /mL (whichever is lower); HIV antibody positive or syphilis antibody positive (and confirmed); 11. Previous treatment toxicity did not return to = grade 1 (except for alopecia, pigmentation, or other toxicity deemed by the investigator to be no safety risk to the subject); 12. Known peripheral neuropathy (CTCAE grade 2 or above); 13. History of severe cardiovascular disease, including but not limited to: (1) Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia and ?-? degree atrioventricular block requiring clinical intervention; (2) QTcF>450 ms in resting state (if QTcF is >450 ms in the first 12-lead ECG, it can be remeasured twice, and the average of the three times is taken) (3) Acute coronary syndrome, congestive heart failure, stroke, or other cardiovascular events of grade 3 or higher within 6 months before the first dose; (4) New York Heart Association functional class >=? or left ventricular ejection fraction <50%; (5) any factors that increase the risk of QTc prolongation or arrhythmia, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death in a first-degree relative younger than 40 years old, use of any comb
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival at 1 year; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);disease free survival (DFS); | — |
Countries
China
Contacts
Public ContactHao ming Lin
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Outcome results
None listed