Pancreatic cancer (PC)
Conditions
Interventions
Experimental Group:Irinotecan liposome + oxaliplatin +5-FU/LV
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The patient had good compliance, could understand the research process of this study, and signed the written informed consent form; 2. Age >=18 years old; 3. Patients who have been diagnosed with pancreatic cancer through histopathology or cytopathology, and whose imaging or pathological examination results suggest the presence of pancreatic cancer but only liver metastasis; 4. Initial treatment patients; 5. According to RECIST1.1 criteria, the patient has at least one evaluable lesion; 6.ECOG 0-1 point; 7. The expected survival time is greater than 3 months; 8. Possessing appropriate organ function, as defined below: (Hematological and blood biochemical tests must be completed within 14 days before enrollment, and the following conditions must be met) a. Absolute neutrophil count (ANC) >=1.5*10^9/L b. Hemoglobin >=90g/dL c. Platelet count (PLT) >=90*10^9/ L. Total bilirubin 1×ULN, creatinine clearance rate >=50mL/min; 9. Women who are not pregnant or breastfeeding; During the study period and within 6 months after the end of the study treatment, women/men of childbearing age should take effective contraceptive measures.
Exclusion criteria
Exclusion criteria: Patients who have suffered from other malignant tumors within the past five years (excluding cured carcinoma in situ and basal cell carcinoma of the skin); 2. Diagnosed as pulmonary fibrosis or interstitial pneumonia; 3. Extrahepatic metastasis exists; 4. Patients who have received a potent CYP3A4 inducer or a potent CYP3A4 inhibitor or a potent UGT1A1 inhibitor simultaneously within 3 weeks before the first administration; 5. Patients known to have dihydropyrimidine dehydrogenase (low activity) or deficiency; 6. Active infection If there is HIV infection or chronic HBV/HCV is in the active stage (such as HBV DNA>=10^4 copies or >=2000IU/mL), antiviral liver-protecting treatment should be carried out first. Only when HBV DNA < 10^4 copies or <2000IU/mL can the patient be enrolled, and antiviral drugs should continue to be taken, liver function and HBV viral load should be monitored). 7. Presence of serious concomitant diseases: such as those with diabetes that cannot be well controlled by hypoglycemic drugs, clinically severe (i.e., active) heart disease, renal failure, liver failure, uncontrolled epilepsy, history of central nervous system diseases or mental disorders, hemorrhagic peptic ulcers, intestinal paralysis, intestinal obstruction, etc. 8. Severe diarrhea; 9. Those who currently or previously have grade =III peripheral neuropathy and have recovered to grade II or lower, and are determined by the researcher to have no safety risk, can be enrolled. 10. Had participated in other clinical researchers within 4 weeks before enrollment; 11. Patients who were assessed by the researchers as unsuitable for the trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactYang Zhiying
China-Japan Friendship Hospital
Outcome results
None listed