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

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Drug: Irinotecan liposome、5-Fluorouracil、Leucovorin
* Drug: Placebo、5-Fluorouracil、Leucovorin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed pancreatic cancer; Unresectable locally advanced or metastatic disease ; Documented disease progression after first-line treatment gemcitabine based therapy ECOG: 0-1; 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized, double-blind, single-dummy, parallel-controlled, multicentre study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group A<br>Irinotecan liposome plus 5-fluorouracil, Leucovorin | Drug: Irinotecan liposome、5-Fluorouracil、Leucovorin<br>* Irinotecan liposome、5-Fluorouracil、Leucovorin<br>|
| Active Comparator: Treatment group B<br>Placebo plus 5-fluorouracil, Leucovorin | Drug: Placebo、5-Fluorouracil、Leucovorin<br>* Placebo、5-Fluorouracil、Leucovorin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival(OS) | OS is defined as the time from randomization to death due to any cause, or censored at date last known alive. | The maximum time in follow up was approximately 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | Progression-free survival was defined as the time from the date of randomization to the date of disease progression, or death (any cause) on or prior to the clinical cutoff date, whichever occurs first. | The maximum time in follow up was 12 months | 
| Objective Response Rate | Objective response rate was based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) | Assessment every 6 weeks after initial response; maximum time on study 12 months | 
| Time to Treatment Failure | Time from randomization to discontinuation of treatment for any reason, including disease progression, treatment toxicity or death. | The maximum time in follow up was 12 months | 
| Percentage of Patients With Tumor Marker (CA 19-9) Response | Response was defined as a decrease of 50% of CA19-9 in relation to the baseline level at least once during the treatment period. | Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 12 months | 
| Quality of life（QoL） | QoL was based on EORTC-QLQ-C30 | Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 12 months |