pancreatic cancer
Conditions
Interventions
AG Sequential NAIRIFOX Treatment Group:Albumin paclitaxel
Sponsors
Subei People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. patients with good compliance, able to understand the study procedures and sign a written informed consent; 2. Age >= 18 years old, gender is not limited; 3. Non-cuttable locally advanced or metastatic pancreatic cancer diagnosed by histology or cytology and without systemic treatment; 4. For subjects who have received prior neoadjuvant or adjuvant therapy, the date of first detection of progression must be >= 6 months from the date of the last dose of neoadjuvant or adjuvant therapy; 5. at least 1 lesion suitable for repeated measurements (CT/MRI, RECIST V1.1) 6. ECOG: 0-1; 7. expected survival time greater than 3 months; 8. have adequate organ function, defined as follows: a. Absolute neutrophil count (ANC) >= 1.5 x 109/L; b. Haemoglobin >= 90 g/dL; c. Platelets (PLT) >= 100 x 10^9/L; d. Total bilirubin < 1.5 times upper limit of normal (ULN); e. Hepatic function indices (AST & ALT) chemistries < 2.5 times upper limit of normal (ULN); f. Serum creatinine (Cr) <= 1.5 x ULN; 9.Non-pregnant or lactating females; females/males of childbearing potential should use effective contraception during the study and for 6 months after completion of study treatment.
Exclusion criteria
Exclusion criteria: 1. those who have been treated with other antineoplastic drugs (including Chinese medicine) before enrolment or those who cannot be assured of treatment and follow-up according to the study requirements after enrolment; 2. Known presence of symptomatic central nervous system metastases and/or carcinomatous meningitis; 3. the presence of serious concomitant diseases: e.g., those who have diabetes mellitus that is not well controlled with glucose-lowering medication, clinically severe (i.e., active) cardiac disease, renal failure, hepatic failure, uncontrolled epilepsy, history of central nervous system disease or psychiatric disorders, haemorrhagic peptic ulcers, intestinal paralysis, and intestinal obstruction; 4. Any other malignant tumour present within the previous 3 years, except cured carcinoma in situ of the uterine cervix and non-melanoma skin cancer; 5. any clinically significant gastrointestinal disease, including liver disease, bleeding, inflammation, obstruction or diarrhoea > grade 2 6. a serious arterial thromboembolic event (myocardial infarction, unstable angina, stroke) within the last 6 months; NYHA (New York Heart Association) class III or IV congestive heart failure, ventricular arrhythmia or uncontrolled blood pressure. Or known ECG abnormalities of clinical significance; 7. active infection or unexplained fever >38.5°C (excluding tumour fever), which in the opinion of the physician may be detrimental to the patient's health; 8. current use or use within the past 2 weeks of strong CYP3A enzyme inducers/inhibitors and/or strong UGT1A inhibitors; 9. Known hypersensitivity to any component of the drug in the study protocol; 10. breastfeeding, known pregnancy, positive serum pregnancy test, or unwillingness to use an effective method of contraception during treatment and within 3 months after the last dose of liposomal irinotecan. Females of childbearing potential must agree to use and be able to use effective contraception (Pearl Index = 2 years, or unless she was surgically sterilised. Males must agree not to have children (including no sperm donation) during the course of the trial and for at least 6 months after the last dose of study drug; 11. patients who, in the opinion of the investigator, are not suitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival ;Objective mitigation rate; | — |
Countries
China
Contacts
Public ContactXianwen Zhang
Subei People's Hospital
Outcome results
None listed