RecruitingPhase 2NCT05959356

Cetuximab and Envafolimab Plus mFOLFOXIRI as First-line Treatment for RAS/BRAF Wild-type, MSS, Unresectable Left-side Metastatic Colorectal Cancer

Cetuximab and Envafolimab Plus mFOLFOXIRI Versus Cetuximab Plus mFOLFOX6 as First-line Treatment for RAS/BRAF Wild-type, MSS, Unresectable Left-side Metastatic Colorectal Cancer: A Randomized Controlled Phase II Trial (CEIL)


Sponsor

Sun Yat-sen University

Enrollment

198 participants

Start Date

Nov 9, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The primary aim of phase II CEIL study is to evaluate the efficacy of cetuximab and envafolimab plus mFOLFOXIRI versus cetuximab plus mFOLFOX6 as first line treatment of patients with initially unresectable and previously untreated RAS/BRAF wild-type, MSS, left-side metastatic colorectal cancer(mCRC), in terms of Progression-free Survival.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of cetuximab (an anti-EGFR antibody), envafolimab (a PD-L1 checkpoint inhibitor), and a chemotherapy regimen called mFOLFOXIRI as a first-line treatment for people with RAS/BRAF wild-type, left-sided, microsatellite stable metastatic colorectal cancer. **You may be eligible if...** - You are 18 or older with confirmed metastatic colorectal cancer that has specific genetic features (RAS/BRAF wild-type, MSS) and is located on the left side of the colon - You have not previously received any systemic treatment for your metastatic cancer - Your overall health is good (ECOG 0–1) and organ function is adequate **You may NOT be eligible if...** - You have had recent blood clots, a heart attack, or serious heart condition in the past 12 months - You have active autoimmune disease, HIV, or active hepatitis B or C - You are currently taking antibiotics for more than a week for an infection - You have uncontrolled fluid buildup around your lungs or abdomen - 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

DRUGCetuximab + Envafolimab + mFOLFOXIRI

Cetuximab 500mg/m² + envafolimab 200mg + irinotecan 150 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2400 mg/m² civ. 46h all on day 1 of each 2 weeks cycle up to max 8 cycles, followed by maintenance with cetuximab 500mg/m² + envafolimab 200mg + leucovorin 200 mg/m² + 5-FU 400 mg/m² + 5-FU 2400 mg/m² civ. 46h all on day 1 of each 2 weeks cycle until PD, unacceptable toxicity or patient's refusal.

DRUGCetuximab + mFOLFOX6

Cetuximab 500mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 400 mg/m² + 5-FU 2400 mg/m² civ. 46h all on day 1 of each 2 weeks cycle up to max 8 cycles, followed by maintenance with cetuximab 500mg/m² + leucovorin 200 mg/m² + 5-FU 400 mg/m² + 5-FU 2400 mg/m² civ. 46h all on day 1 of each 2 weeks cycle until PD, unacceptable toxicity or patient's refusal.


Locations(3)

The First People's Hospital of Foshan

Foshan, Guangdong, China

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Affiliated Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, China

View Full Details on ClinicalTrials.gov

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NCT05959356


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