Back to resultsIrinotecan Liposome in Combination With 5-FU/LV Versus 5-FU/LV in Second-line Therapy for Gemcitabine-Refractory Pancreatic Cancer
Primary Purpose
Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer After Treatment Failure With Gemcitabine-based Therapy
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Irinotecan liposome、5-Fluorouracil、Leucovorin
Placebo、5-Fluorouracil、Leucovorin
Sponsored by
About this trial
This is an interventional treatment trial for Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer After Treatment Failure With Gemcitabine-based Therapy
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
- 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.
Sites / Locations
- Qinhuai Medical Area, General Hospital of PLA Eastern Theater Command
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment group A
Treatment group B
Arm Description
Irinotecan liposome plus 5-fluorouracil, Leucovorin
Placebo plus 5-fluorouracil, Leucovorin
Outcomes
Primary Outcome Measures
Overall Survival(OS)
OS is defined as the time from randomization to death due to any cause, or censored at date last known alive.
Secondary Outcome Measures
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.
Objective Response Rate
Objective response rate was based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Time to Treatment Failure
Time from randomization to discontinuation of treatment for any reason, including disease progression, treatment toxicity or death.
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.
Quality of life（QoL）
QoL was based on EORTC-QLQ-C30
Full Information
NCT ID
NCT05074589
First Posted
September 29, 2021
Last Updated
August 9, 2023
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05074589
Brief Title
Irinotecan Liposome in Combination With 5-FU/LV Versus 5-FU/LV in Second-line Therapy for Gemcitabine-Refractory Pancreatic Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 25, 2018 (Actual)
Primary Completion Date
November 18, 2021 (Actual)
Study Completion Date
March 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer After Treatment Failure With Gemcitabine-based Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A randomized, double-blind, single-dummy, parallel-controlled, multicentre study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
298 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group A
Arm Type
Experimental
Arm Description
Irinotecan liposome plus 5-fluorouracil, Leucovorin
Arm Title
Treatment group B
Arm Type
Active Comparator
Arm Description
Placebo plus 5-fluorouracil, Leucovorin
Intervention Type
Drug
Intervention Name(s)
Irinotecan liposome、5-Fluorouracil、Leucovorin
Intervention Description
Irinotecan liposome、5-Fluorouracil、Leucovorin
Intervention Type
Drug
Intervention Name(s)
Placebo、5-Fluorouracil、Leucovorin
Intervention Description
Placebo、5-Fluorouracil、Leucovorin
Primary Outcome Measure Information:
Title
Overall Survival(OS)
Description
OS is defined as the time from randomization to death due to any cause, or censored at date last known alive.
Time Frame
The maximum time in follow up was approximately 12 months
Secondary Outcome Measure Information:
Title
Progression Free Survival
Description
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.
Time Frame
The maximum time in follow up was 12 months
Title
Objective Response Rate
Description
Objective response rate was based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Time Frame
Assessment every 6 weeks after initial response; maximum time on study 12 months
Title
Time to Treatment Failure
Description
Time from randomization to discontinuation of treatment for any reason, including disease progression, treatment toxicity or death.
Time Frame
The maximum time in follow up was 12 months
Title
Percentage of Patients With Tumor Marker (CA 19-9) Response
Description
Response was defined as a decrease of 50% of CA19-9 in relation to the baseline level at least once during the treatment period.
Time Frame
Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 12 months
Title
Quality of life（QoL）
Description
QoL was based on EORTC-QLQ-C30
Time Frame
Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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.
Facility Information:
Facility Name
Qinhuai Medical Area, General Hospital of PLA Eastern Theater Command
City
Nanjing
State/Province
Jiangsu
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Irinotecan Liposome in Combination With 5-FU/LV Versus 5-FU/LV in Second-line Therapy for Gemcitabine-Refractory Pancreatic Cancer
We'll reach out to this number within 24 hrs