RecruitingPhase 2NCT07044921

Clinical Study of Irinotecan Liposome (II)-Based Combination Treatment for Irinotecan-resistant Colorectal Cancer.

A Single-center Phase II Clinical Study of Irinotecan Liposome (II)-Based Combination Regimen as a Treatment for Irinotecan-Resistant Colorectal Cancer.


Sponsor

Chinese PLA General Hospital

Enrollment

30 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Phase II clinical study of irinotecan liposome (II)-based combination regimen as a treatment for irinotecan-resistant colorectal cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new form of the chemotherapy drug irinotecan (a liposomal version — wrapped in tiny fat particles to improve delivery) combined with other treatments for colorectal cancer that has stopped responding to standard irinotecan-based therapy. The goal is to see if this reformulated drug can overcome resistance. **You may be eligible if...** - You are 18 or older with colorectal cancer - Your cancer progressed during or after treatment that included standard irinotecan - You have measurable cancer on imaging - Your overall health and organ function are adequate - You have not had more than a specified number of prior treatment lines **You may NOT be eligible if...** - You have active brain metastases - You have significant heart, liver, or kidney problems - You have uncontrolled infections or bleeding disorders - You are pregnant or breastfeeding - You have had certain prior cancer treatments that overlap with study drugs 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 Liposomes (II)+Cetuximab+Bevacizumabl

Irinotecan Liposomes (II) injection:Intravenous infusion, 60 mg/m2, Day 1, Q2W. The recommended initial dosage of irinotecan liposomes (II) for patients with the UGT1A1 \* 28/\* 6 homozygous mutation is 47.1 mg/m2. Cetuximab injection:Intravenous infusion, 500 mg/m2, Day 1, Q2W. Bevacizumabl: Intravenous infusion, 5mg/kg, Day 1, Q2W.


Locations(1)

Chinese PLA General Hospital, Beijing,

Beijing, China

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NCT07044921


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