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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

298 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-25

Study Completion Date

2022-03-10

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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized, double-blind, single-dummy, parallel-controlled, multicentre study

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment group A

Irinotecan liposome plus 5-fluorouracil, Leucovorin

Group Type EXPERIMENTAL

Irinotecan liposome、5-Fluorouracil、Leucovorin

Intervention Type DRUG

Irinotecan liposome、5-Fluorouracil、Leucovorin

Treatment group B

Placebo plus 5-fluorouracil, Leucovorin

Group Type ACTIVE_COMPARATOR

Placebo、5-Fluorouracil、Leucovorin

Intervention Type DRUG

Placebo、5-Fluorouracil、Leucovorin

Interventions

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Irinotecan liposome、5-Fluorouracil、Leucovorin

Intervention Type DRUG

Placebo、5-Fluorouracil、Leucovorin

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No