Real-world Study to Evaluate the Efficacy and Safety of Liposome Irinotecan

Sponsor
Peking University
Study ID
NCT06443307
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan Liposome — DRUG
    The experimental group will collect data from patients treated with Nal-IRI as the chemotherapy regimen. It is recommended to use according to the label, clinical practice shall prevail.

Study Details

This study is a prospective, multicenter, real-world study. There are four cohorts. Cohorts 1-3 include second-line, posterior-line, and neoadjuvant colorectal cancer patients, respectively. Cohort 4 include patients with the exception of those with pancreatic and colorectal cancer. As this study is a real-world investigation, treatment procedures, visit schedules, and examinations will be based on the routine clinical practice of physicians. Through the above cohort, the efficacy and safety of irinotecan liposome are comprehensively observed.

Key Dates

Start date
Jul 15, 2024
Status verified
May 2024
Primary completion
Jul 1, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
933 participants (estimated)

Arms

  • Arm: Second-line treatment for colorectal cancer
    Cohort 1 is a concurrent control design, including patients treated with irinotecan liposome (Nal-IRI) or irinotecan (IRI) plus fluorouracils as second-line treatment for metastatic colorectal cancer.
  • Arm: Posterior line treatment of colorectal cancer
    Cohort 2 is a Simon two-stage design, is planned to include patients who are treated with a NAL-IRI based combination regimen and have used IRI as a late-line treatment for metastatic colorectal cancer.
  • Arm: Neoadjuvant therapy for colorectal cancer
    Cohort 3 is a single-arm design and planned to enroll patients who received Nal-IRI+ oxaliplatin + fluorouracils as neoadjuvant chemotherapy for colorectal cancer.
  • Arm: Patients with non-pancreatic and non-colorectal cancer received second-line or above treatment
    Cohort 4 is a single-arm design and is planned to enroll patients who are treated with the NAL-IRI containing regimen as second-line or beyond treatment for nonpancreatic, noncolorectal cancers.

Primary Outcome Measure

Incidence of grade ≥3 adverse events assessed by CTCAE 5.0 (Cohort 1) [ Time Frame: Assessed except to 10 months. ]

Central Contacts

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