Irinotecan Liposome in Combination With 5-FU/LV Versus 5-FU/LV in Second-line Therapy for Gemcitabine-Refractory Pancreatic Cancer

A Randomized, Double-blind, Single-dummy, Parallel-controlled, Multicentre, Phase III Clinical Study of Irinotecan Hydrochloride Liposome in Combination With 5-FU/LV as Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer After Treatment Failure With Gemcitabine-based Therapy

To evaluate efficacy and safety of irinotecan hydrochloride liposome in combination with 5-FU/LV as second-line treatment for locally advanced or metastatic pancreatic cancer after treatment failure with gemcitabine-based therapy.

Inclusion Criteria:

1. Histologically or cytologically confirmed pancreatic cancer;
2. Unresectable locally advanced or metastatic disease ;
3. Documented disease progression after first-line treatment gemcitabine based therapy
4. ECOG: 0-1;
5. Adequate organ and bone marrow function;
6. sign an informed consent.

Exclusion Criteria:

1. Active CNS metastasis;
2. Uncontrolled tumor-related pain;
3. Clinically significant GI disorders;
4. Significant cardiovascular disease;
5. Active infection or uncontrolled fever;
6. Pregnant or breast feeding patients;
7. Allergic to a drug ingredient or component;
8. The investigators determined that other conditions were inappropriate for participation in this clinical trial.