RecruitingPhase 2NCT06184698

Liposomal Irinotecan and Leucovorin/5-fluorouracil Plus Bevacizumab in Metastatic Colorectal Cancer

Liposomal Irinotecan + Leucovorin + 5-fluorouracil + Bevacizumab as Second-line Therapy in Metastatic Colorectal Cancer (IRIS):a Multicenter, Single-arm, Prospective, Phase II Study


Sponsor

Hebei Medical University Fourth Hospital

Enrollment

173 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Summary

This is a multi-center, single-arm study to investigate the efficacy and safety of liposomal irinotecan+5-FU/LV+ bevacizumab as second-line therapy in metastatic colorectal cancer in Chinese population.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of chemotherapy drugs — liposomal irinotecan, leucovorin, 5-fluorouracil, and bevacizumab — as a second-line treatment for people with colorectal cancer that has spread to other parts of the body and cannot be removed by surgery. **You may be eligible if...** - You are between 18 and 75 years old - You have colorectal cancer confirmed by biopsy or lab test - Your cancer has spread and cannot be surgically removed - You have already received first-line chemotherapy that included oxaliplatin - You are in reasonably good health (able to carry out daily activities with minimal limitations) **You may NOT be eligible if...** - Your cancer has not been previously treated - You have serious heart, liver, or kidney problems - You are pregnant or breastfeeding - You have already tried bevacizumab or irinotecan 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

DRUGliposomal irinotecan

liposomal irinotecan 70 mg/m²

DRUG5-FU

5-FU 2400 mg/m²

DRUGLV

5-FU 2400 mg/m²

DRUGBevacizumab

bevacizumab 5 mg/kg


Locations(1)

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

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NCT06184698