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

Phase 3

Completed

• Conditions: Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer After Treatment Failure With Gemcitabine-based Therapy
• Interventions: Drug: Irinotecan liposome、5-Fluorouracil、Leucovorin; Drug: Placebo、5-Fluorouracil、Leucovorin

• Registration Number: NCT05074589
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-25
• Study First Submitted: 2021-09-29
• Study First Submitted QC: 2021-09-29
• Study First Posted: 2021-10-12
• Primary Completion: 2021-11-18
• Study Completion: 2022-03-10
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-09
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group A	Irinotecan liposome、5-Fluorouracil、Leucovorin	Irinotecan liposome plus 5-fluorouracil, Leucovorin
Treatment group B	Placebo、5-Fluorouracil、Leucovorin	Placebo plus 5-fluorouracil, Leucovorin

Primary Outcome Measures

Name	Time	Method
Overall Survival(OS)	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 Outcome Measures

Name	Time	Method
Progression Free Survival	The maximum time in follow up was 12 months	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	Assessment every 6 weeks after initial response; maximum time on study 12 months	Objective response rate was based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Time to Treatment Failure	The maximum time in follow up was 12 months	Time from randomization to discontinuation of treatment for any reason, including disease progression, treatment toxicity or death.
Quality of life（QoL）	Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 12 months	QoL was based on EORTC-QLQ-C30
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	Response was defined as a decrease of 50% of CA19-9 in relation to the baseline level at least once during the treatment period.

Trial Locations

Locations (1)

Qinhuai Medical Area, General Hospital of PLA Eastern Theater Command; 🇨🇳 Nanjing, Jiangsu, China