RecruitingPhase 2NCT06341296

Phase II Study of Irinotecan Liposomes in First-line Treatment of Metastatic Colorectal Cancer

Phase II Study of Irinotecan Liposomes Combined With 5-FU/LV+ Bevacizumab in First-line Treatment of Metastatic Colorectal Cancer


Sponsor

West China Hospital

Enrollment

86 participants

Start Date

Jun 30, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the objective response rate, disease control rate, progression-free survival, overall survival, surgical conversion rate and safety of irinotecan liposome combined with 5-FU/LV+ bevacizumab regimen in first-line treatment of advanced metastatic colorectal cancer patients.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a newer form of the chemotherapy drug irinotecan (delivered inside tiny fat bubbles called liposomes) as a first-line treatment for colorectal cancer that has spread and cannot be surgically removed. Researchers want to see if this approach works better than standard treatments for people with specific tumor characteristics. **You may be eligible if...** - You are between 18 and 85 years old - You have been diagnosed with colorectal cancer that has spread and cannot be operated on - Your tumor has been tested and found to have RAS or BRAF mutations, or the cancer started on the right side of the colon - Your cancer has not yet received any systemic (whole-body) treatment - You are generally active and able to care for yourself (good performance status) - Your blood counts, liver, and kidney function are within acceptable ranges **You may NOT be eligible if...** - The cancer has spread to your brain or spinal cord - You have previously received irinotecan or bevacizumab - You had surgery or cancer treatment in the last 4 weeks - You have serious bowel problems such as obstruction or perforation - You have interstitial lung disease - You are pregnant or breastfeeding 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

70 mg/m\^2 , d1, 14 days per cycle, 8 cycles.

DRUG5-FU

5-FU 400mg/m\^2, then 2400mg/m\^2, continuous intravenous infusion for 46-48h, d1-2, 14 days per cycle, 8 cycles.

DRUGLV

400mg/m\^2, d1, 14 days per cycle, 8 cycles.

DRUGBevacizumab

5mg/kg, d1, 14 days per cycle, 8 cycles.


Locations(1)

West China Hospital,Sichuan University

Sichuan, Sichuan, Chengdu, China

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NCT06341296


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