Bioequivalence Study of Irinotecan Liposome Injection in Chinese Advanced Pancreatic Cancer.

Inclusion Criteria:

1. Signed written informed consent for participation in the trial.

2. Advanced pancreatic cancer diagnosed by histopathology and / or cytology.

3. Age ≥ 18 years, men or women. BMI is above 17.

4. ECOG score 0 to 2.

5. Life expectancy ≥ 3 months.

6. Adequate bone marrow function.

7. Adequate hepatic function.

8. Adequate renal function.

9. Patient with reproductive potential must agree to use adequate contraception from thesigning of informed consent to at least 6 months after the trial

Exclusion Criteria:

1. Patients who have a severe allergy or a significant history of hypersensitivity or anidiopathic reaction attributed to irinotecan or compounds of similar chemicalcomposition to irinotecan ;

2. Patients who have previously used irinotecan liposomes and experienced treatmentfailure or serious adverse reactions;

3. Patients with severe cardiovascular, lung, liver, kidney, gastrointestinal, endocrine,immune system, skin, musculoskeletal, neurological or psychiatric diseases thatoccurred within 3 months of the first dose of the study drug, and not suitable forthis study as determined by the researchers;

4. Patients who have undergone major surgery within 4 weeks of screening or have aschedule for major surgery during the study period;

5. Patients who have received any radiotherapy or chemotherapy and other anti-tumortreatment within 4 weeks of the first dose of the study drug, traditional Chinesemedicine with anti-tumor indications within 4 weeks of the first dose of the studydrug, or small molecule targeted drugs within 2 weeks (or 5 half-lives whichever islonger) of the first dose of the study drug;

6. Patients who currently enrolled in any other clinical study, or received otherinvestigational agents within 4 weeks of the first dose of the study drug；

7. Blood donation or massive blood loss (>400mL) within 90 days of screening;

8. Concomitant use of strong CYP3A4 inhibitors or inducers, or UGT1A1 inhibitors within 4weeks of the first dose of the study drug;

9. Patients who received certain diet (such as grapefruit) which may interfere with theevaluation of PK results;

10. LVEF≤50%;

11. Patients with extended QT/QTc interval (QTcF>480ms);

12. History of alcohol or drugs abuse;

13. Pregnant or lactating women;

14. Patients with known Hepatitis B Virus (HBV DNA≥104), Hepatitis C Virus (anti-HCVpositive, HCV RNA positive), Human immunodeficiency virus antibody (anti-HIVpositive), or active Treponema Pallidum viral infection;

15. Patients with homozygous UGT1A128 genotype or UGT1A16 genotype;

16. Patients who are not suitable for this study as determined by the researchers.