RecruitingPhase 2NCT05962502

Cetuximab Plus Irinotecan in Patients With NeoRAS Wild-type Metastatic Colorectal Cancer In Third-line Therapy

A Single-arm, Open-label, Phase II Clinical Study of Cetuximab Plus Irinotecan in Patients With NeoRAS Wild-type Metastatic Colorectal Cancer In Third-line Therapy


Sponsor

Sun Yat-sen University

Enrollment

54 participants

Start Date

Aug 24, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-arm, open-label, phase II clinical trial. The goal of this study is to evaluate the efficacy and safety of cetuximab plus irinotecan in patients with NeoRAS wild-type primary left-sided mCRC in third-line therapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a combination of the chemotherapy drugs cetuximab and irinotecan can help patients with metastatic colorectal cancer (cancer that has spread) who originally had a RAS mutation but whose cancer has now converted to "NeoRAS wild-type" — meaning the mutation is no longer detectable — after earlier rounds of treatment. **You may be eligible if...** - You are 18 or older with confirmed colorectal cancer that has spread - Your cancer originally had a RAS mutation but now tests negative for RAS mutation (NeoRAS wild-type) based on liquid biopsy - You have already received two prior lines of standard treatment (including fluorouracil, oxaliplatin, and irinotecan-based therapies) - Your overall health is adequate for further chemotherapy **You may NOT be eligible if...** - Your cancer still has a detectable RAS mutation - You have a BRAF mutation in your tumor - You have not received prior standard chemotherapy regimens - You have severe organ dysfunction or other conditions that prevent chemotherapy 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

DRUGCetuximab and irinotecan

chemotherapy plus targeted therapy


Locations(1)

Cancer center of Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT05962502


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