Pancreatic Cancer
Conditions
Interventions
Therapeutic Group:Irinotecan liposome injection combined with oxaliplatin, 5-FU/LV.
Sponsors
Wuxi People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Able and willing to provide a written informed consent. 2. Age >=18 years old, gender unlimited; 3. Histologically confirmed resected ductal pancreatic adenocarcinoma, with unresectable pancreatic ductal adenocarcinoma whose imaging or pathological findings suggest local progression or distant metastasis; 4. Progression after gemcitabine + albumin-bound paclitaxel-based neoadjuvant therapy, adjuvant therapy (distant metastasis occurs within 6 months after completion of adjuvant therapy), locally advanced or metastatic first-line therapy; 5. Karnofsky performance status >=70 6. Patients with at least one repeatable lesion according to RECIST1.1 criteria 7. Life expectancy of greater than or equal to 3 months. 8. Adequate organ function: specifically, bone marrow function: blood routine examination criteria (no blood transfusion or hematopoietic stimulating factor drug correction within 7 days before screening) : hemoglobin (HGB) >=100g/L; Absolute neutrophil count (NEUT) >=1.5×10^9/L; Platelet (PLT) >=100×10^9/L, white blood cell (WBC) >=3.0×10^9/L; Liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) =60ml/min (calculated by Cockroft-Gault). 9. Patients with proper nutritional status 10. Non-pregnant or lactating women; Effective contraception should be used by women/men of childbearing age during the study period and for 6 months after the end of study treatment.
Exclusion criteria
Exclusion criteria: 1. Previous use or known allergy to irinotecan liposomes, oxaliplatin, 5-FU/LV and other related ingredients; 2. Patients who have had other malignancies within the previous 5 years (except cured carcinoma in situ and skin basal cell carcinoma); 3. Pulmonary fibrosis or interstitial pneumonia was diagnosed within 28 days prior to enrollment. 4. Any known brain or meningeal metastases; 5. Patients who were co-administered a potent CYP3A4 inducer within 3 weeks prior to first dosing, or a potent CYP3A4 inhibitor or a potent UGT1A1 inhibitor within 3 weeks prior to first dosing 6. Patients who underwent large organ surgery (except needle biopsy, central venous catheterization, port catheterization, stenting for relief of biliary obstruction, percutaneous hepatobiliary drainage, cholecystostomy) or an elective surgical program within 4 weeks prior to the first dose of the study drug; 7. Patients with known dihydropyrimidine dehydrogenase (low activity) or deficiency; 8. Patients with active infectious disease: If HIV infection, chronic HBV/HCV in active stage (HBV DNA >=104 copies or >=2000IU/mL), antiviral liver protection therapy should be given first, and HBV DNA < 104 copies or < 2000IU/mL can be enrolled. And continue to take antiviral drugs, monitor liver function and HBV viral load). 9. Patient with serious concomitant disease:such as diabetes mellitus that cannot be well controlled by hypoglycemic drugs, clinically severe (active) heart disease, renal failure, liver failure, uncontrolled epilepsy, history of central nervous system disease or mental disorder, hemorrhagic peptic ulcer, ileus, intestinal obstruction, etc. 10. Patients with severe digestive tract diseases(including active bleeding, Grade1 or above obstruction, or Grade1 or above diarrhea [CTCAE v5.0]); 11. People with severe mental illness 12. Patients with current or past grade III peripheral neuropathy who have recovered to grade II or below can be enrolled without safety risk as determined by the investigators; 13. Patients who had participated in other clinical studies within 4 weeks prior to enrollment; 14. Patients who were deemed unfit to participate in the trial assessed by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective Response Rate; | — |
Countries
China
Contacts
Public ContactHuiyu Wang
Wuxi People's Hospital
Outcome results
None listed