Actively Recruiting
Cetuximab and Envafolimab Plus mFOLFOXIRI as First-line Treatment for RAS/BRAF Wild-type, MSS, Unresectable Left-side Metastatic Colorectal Cancer
Led by Sun Yat-sen University · Updated on 2025-12-17
198
Participants Needed
3
Research Sites
268 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cetuximab and Envafolimab Plus mFOLFOXIRI as First-line Treatment for RAS/BRAF Wild-type, MSS, Unresectable Left-side Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and able to understand study procedures
- Male or female aged 18 years or older with expected lifespan of at least 12 weeks
- Histologically or cytologically confirmed RAS and BRAF wild-type, MSS metastatic colorectal adenocarcinoma (excluding appendiceal and anal cancers)
- AJCC/UICC stage IV left-side metastatic colorectal cancer with at least one measurable lesion per RECIST 1.1
- No prior systemic treatment for advanced or metastatic colorectal cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function based on recent lab tests within 7 days before treatment
- Negative pregnancy test for women of childbearing potential at baseline
- Not participating in other clinical trials and willing to comply with study protocol
You will not qualify if you...
- Concurrent active malignancy except those with disease-free survival of 5 years or more or cured in situ carcinoma
- Diagnosed gastrointestinal diseases causing bleeding or obstruction
- Thrombotic or embolic events within 12 months before enrollment
- Recent serious heart conditions or arrhythmias within 12 months before enrollment
- Use of systemic antibiotics for 7 or more days within 4 weeks before enrollment or unexplained fever
- Uncontrolled pleural effusion, ascites, or pericardial effusion within 14 days before enrollment
- Unresolved adverse events grade 2 or higher from previous treatments
- Interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases
- Known HIV infection or active hepatitis B or C
- Allergy to any investigational drug used in the study
- Pregnant or lactating women
- Pre-menopausal women who do not use or refuse effective non-hormonal contraception or fertile men
- Other significant physical or mental illnesses or lab abnormalities increasing study risk or interfering with results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
The First People's Hospital of Foshan
Foshan, Guangdong, China, 528000
Actively Recruiting
2
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510655
Actively Recruiting
3
Affiliated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, China, 550000
Actively Recruiting
Research Team
Y
Yanhong Deng, Ph.D
CONTACT
X
Xiaoyu Xie, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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