RecruitingPhase 2NCT05727163

FOLFOX Via HAI Plus Intravenous Irinotecan With or Without Bevacizumab Versus Systemic FOLFOXIRI With or Without Bevacizumab in Initially Unresectable RAS-mutated CRLM Patients

FOLFOX Via Hepatic Artery Infusion Chemotherapy (HAI) Plus Systemic Irinotecan With or Without Bevacizumab Versus Systemic FOLFOXIRI With or Without Bevacizumab in Patients With Initially Unresectable RAS-mutated Colorectal Cancer With Liver Metastases: A Prospective, Randomized, Controlled Clinical Study


Sponsor

Sun Yat-sen University

Enrollment

194 participants

Start Date

Jul 29, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This prospective, randomized, controlled clinical study aims to evaluate the objective remission rate of FOLFOX hepatic artery infusion chemotherapy (HAI) in combination with systemic irinotecan with or without bevacizumab versus systemic intravenous FOLFOXIRI with or without bevacizumab in initially unresectable RAS-mutated colorectal cancer patients with liver metastases.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two different chemotherapy strategies for people with colorectal cancer that has spread to the liver and cannot be surgically removed. One approach delivers chemo directly into the liver artery (hepatic arterial infusion, or HAI) plus IV chemo; the other uses a standard full-body chemo regimen. Both may include the targeted drug bevacizumab. **You may be eligible if...** - You have confirmed colorectal cancer with liver metastases that cannot be removed by surgery - Your cancer has RAS or BRAF mutations - You have not previously received chemotherapy for your liver metastases **You may NOT be eligible if...** - You have had previous treatment specifically for your liver metastases - You have cancer that has spread beyond the liver - You have serious liver or blood clotting problems 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

DRUGDexamethasone

25mg via HAI (Pre-chemotherapy)

DRUGAnisodamine

10 mg via HAI (Pre-chemotherapy)

DRUGOxaliplatin

85 mg/m2 via HAI over 3 hours

DRUGLeucovorin

200 mg/m2 via HAI

DRUGFluorouracil

400 mg/m2 via HAI and 2.4g/m2 via HAI over 48 hours

DRUGIrinotecan

150 mg/m2 intravenously

DRUGBevacizumab

5 mg/kg intravenously

DRUGOxaliplatin

85 mg/m2 intravenously over 3 hours

DRUGLeucovorin

200 mg/m2 intravenously

DRUGFluorouracil

400 mg/m2 intravenously + 2400 mg/m2 continuous intravenous infusion over 46 hours


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

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NCT05727163


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