Treatment of Irinotecan Hydrochloride Liposome Injection II in China: a Real World Study of Pancreatic Cancer Patients

Sponsor
Peking Union Medical College Hospital
Study ID
NCT06375473
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This study is a multi-center observational study.The start time for data collection is May 1, 2024. Patients' baseline and treatment data will be collected under informed concent. The purpose of this case registry study was to evaluate the safety and efficacy of irinotecan hydrochloride liposome injection II based therapy in Chinese patients with pancreatic cancer in the real world by collecting, understanding, and analyzing the etiology, clinical features, treatment pattern, treatment outcomes, and pharmacoeconomics changes in pancreatic cancer patients receiving this regimen.

Key Dates

Start date
Apr 19, 2024
Status verified
Dec 2025
Primary completion
Apr 19, 2027
Completion
Apr 19, 2027

Study Design

Enrollment
3,000 participants (estimated)

Arms

  • Arm: Perioperative cohort
    Irinotecan liposome II combination therapy regimen for perioperative patients
  • Arm: First line cohort
    Irinotecan liposome II combination therapy regimen for first line advanced patients
  • Arm: Second line cohort
    Irinotecan liposome II combination therapy regimen for second line advanced patients
  • Arm: Late stage third line and above cohort
    Irinotecan liposome II combination therapy regimen for third line and above advanced patients

Primary Outcome Measure

rwTEAE [ Time Frame: 3 years ]

Central Contacts

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