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

• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05074589
• Collaborator: (none)
• Enrollment: 298
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 50.9
• Patients Per Site Per Month: 5.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer After Treatment Failure With Gemcitabine-based Therapy	Drug: Irinotecan liposome、5-Fluorouracil、Leucovorin; Drug: Placebo、5-Fluorouracil、Leucovorin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 298 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A randomized, double-blind, single-dummy, parallel-controlled, multicentre studyA randomized, double-blind, single-dummy, parallel-controlled, multicentre study
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 25, 2018
• Anticipated Primary Completion Date: Dec 8, 2021
• Anticipated Study Completion Date: Apr 23, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment group A Irinotecan liposome plus 5-fluorouracil, Leucovorin	Drug: Irinotecan liposome、5-Fluorouracil、Leucovorin; Irinotecan liposome、5-Fluorouracil、Leucovorin
Active Comparator: Treatment group B Placebo plus 5-fluorouracil, Leucovorin	Drug: Placebo、5-Fluorouracil、Leucovorin; Placebo、5-Fluorouracil、Leucovorin

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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)

3. 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.

4. 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.

5. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Qinhuai Medical Area, General Hospital of PLA Eastern Theater Command	Nanjing	Jiangsu	China

Sponsors and Collaborators

• Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05074589
• Other Study ID Numbers: HR-IRI-APC
• First Posted: Oct 12, 2021
• Last Update Posted: Oct 12, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pancreatic Neoplasms; Leucovorin; Fluorouracil; Irinotecan; Levoleucovorin

Study Results

No Results Posted as of Oct 12, 2021