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

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country298 target enrollmentJanuary 25, 2018

ConditionsSecond-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer After Treatment Failure With Gemcitabine-based Therapy

InterventionsIrinotecan liposome、5-Fluorouracil、Leucovorin Placebo、5-Fluorouracil、Leucovorin

DrugsIrinotecan liposome、5-Fluorouracil、Leucovorin Placebo、5-Fluorouracil、Leucovorin

Overview

Phase: Phase 3
Intervention: Irinotecan liposome、5-Fluorouracil、Leucovorin
Conditions: Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer After Treatment Failure With Gemcitabine-based Therapy
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 298
Locations: 1
Primary Endpoint: Overall Survival(OS)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 25, 2018

End Date

March 10, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically or cytologically confirmed pancreatic cancer;
•Unresectable locally advanced or metastatic disease ;
•Documented disease progression after first-line treatment gemcitabine based therapy
•Adequate organ and bone marrow function;
•sign an informed consent.

Exclusion Criteria

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

Arms & Interventions

Treatment group A

Irinotecan liposome plus 5-fluorouracil, Leucovorin

Intervention: Irinotecan liposome、5-Fluorouracil、Leucovorin

Treatment group B

Placebo plus 5-fluorouracil, Leucovorin

Intervention: Placebo、5-Fluorouracil、Leucovorin

Outcomes

Primary Outcomes

Overall Survival(OS)

Time Frame: The maximum time in follow up was approximately 12 months

OS is defined as the time from randomization to death due to any cause, or censored at date last known alive.

Secondary Outcomes

Progression Free Survival(The maximum time in follow up was 12 months)
Objective Response Rate(Assessment every 6 weeks after initial response; maximum time on study 12 months)
Time to Treatment Failure(The maximum time in follow up was 12 months)
Quality of life（QoL）(Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 12 months)
Percentage of Patients With Tumor Marker (CA 19-9) Response(Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 12 months)