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Completed

NCT Number: NCT05074589

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

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Qinhuai Medical Area, General Hospital of PLA Eastern Theater Command

Nanjing, Jiangsu, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Irinotecan liposome、5-Fluorouracil、Leucovorin

Drug

Irinotecan liposome、5-Fluorouracil、Leucovorin

Placebo、5-Fluorouracil、Leucovorin

Drug

Placebo、5-Fluorouracil、Leucovorin

Primary outcomes

  1. Overall Survival(OS)

    Time frame: 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 outcomes

  1. Progression Free Survival

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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）

    Time frame: Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 12 months

    QoL was based on EORTC-QLQ-C30

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Oct 12, 2021
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.