RecruitingNCT06443307

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

A Prospective, Multi-cohort, National Multicenter Real-world Study to Evaluate the Efficacy and Safety of Liposome Irinotecan


Sponsor

Peking University

Enrollment

933 participants

Start Date

Jul 15, 2024

Study Type

OBSERVATIONAL

Summary

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This real-world study tracks how well liposome irinotecan (a chemotherapy drug with a special fat-based coating that helps deliver it into tumor cells) works for people with metastatic colorectal cancer or pancreatic cancer that has stopped responding to earlier treatments. **You may be eligible if...** - You have confirmed colorectal cancer (bowel cancer) or pancreatic cancer that has spread (metastatic disease) - Your cancer has stopped responding to standard first or second-line chemotherapy - You are being treated with liposome irinotecan as part of your regular care **You may NOT be eligible if...** - You have already received irinotecan or liposome irinotecan as a prior treatment - You have certain types of colorectal cancer that are not included in the study (e.g., MSI-high/MMR-deficient) - You have serious organ dysfunction that would prevent safe treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIrinotecan Liposome

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.


Locations(1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

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NCT06443307