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

HR-IRI-APC

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.

2018-01-25

2021-11-18

2022-03-10

Completed

Early phase I

298

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.

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2023-08-14