RecruitingPhase 2NCT06643793

Evaluation of Irinotecan Liposome (II) Combined With 5-FU, LV, and Bevacizumab for mCRC

Evaluation of Irinotecan Liposome (II) Combined With 5-fluorouracil, Leucovorin, and Bevacizumab for Second-line/Third-line Treatment of Metastatic Colorectal Cancer (mCRC): a Prospective and Exploratory Clinical Study


Sponsor

Affiliated Hospital of Nantong University

Enrollment

30 participants

Start Date

Nov 4, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To observe and evaluate the efficacy and safety of irinotecan liposome (II) combined with 5-fluorouracil(5-FU), calcium leucovorin(LV), and bevacizumab in the treatment of metastatic colorectal cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of chemotherapy drugs — including an irinotecan liposome injection, 5-FU, leucovorin, and bevacizumab — as a treatment for advanced colorectal cancer that has spread and cannot be removed by surgery. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with stage IV colon or rectal cancer that cannot be surgically removed - Your cancer has progressed or you could not tolerate a prior chemotherapy regimen containing oxaliplatin - You are in generally good physical health (able to carry out light activity) - Your heart, liver, kidneys, and blood counts meet required levels **You may NOT be eligible if...** - You have had a different cancer in the past 5 years - Your cancer has a specific genetic marker (MSI-H or BRAF V600E mutation) suggesting other treatments may work better - Your cancer has spread to the brain - You have previously received irinotecan-based chemotherapy - You have serious heart, lung, or digestive problems - 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 (ll) + 5-FU/LV + bevacizumab

1. Bevacizumab: 5 mg/kg, d1, q2w; 2. Irinotecan Hydrochloride Liposomal Injection (II): 60 mg/m2, d1, q2w; 3. leucovorin: 400 mg/m2, d1, q2w; 4. 5-fluorouracil: 2800 mg/m2, d1, q2w.


Locations(1)

Affiliated Hospital Of Nantong University

Nanjing, Jiangsu, China

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NCT06643793


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