Actively Recruiting
First-line mCapOX+Cetuximab vs. mFOLFOX6+Cetuximab for Metastatic Left-sided CRC With Wild-type RAS/BRAF Genes
Led by West China Hospital · Updated on 2024-03-07
150
Participants Needed
1
Research Sites
253 weeks
Total Duration
On this page
Sponsors
W
West China Hospital
Lead Sponsor
F
First Affiliated Hospital of Chongqing Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This prospective, randomized, phase 2 study is conducted to evaluate the efficacy and safety of first line mCapOX plus cetuximab versus mFOLFOX6 plus cetuximab for metastatic left-sided CRC patients with wild-type RAS and BRAF genes.
CONDITIONS
Official Title
First-line mCapOX+Cetuximab vs. mFOLFOX6+Cetuximab for Metastatic Left-sided CRC With Wild-type RAS/BRAF Genes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent and comply with study requirements
- Men and women aged 18 years or older
- Diagnosed with metastatic left-sided colorectal adenocarcinoma with wild-type RAS and BRAF genes
- At least one measurable lesion according to RECIST Version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- No prior first-line chemotherapy, targeted therapy, immunotherapy, or platinum-based adjuvant chemotherapy within 12 months
- Initial unresectable synchronous metastatic colorectal cancer without serious complications such as obstruction, perforation, or massive hemorrhage
- Life expectancy longer than 3 months
- Laboratory values within specified ranges including neutrophils, platelets, hemoglobin, bilirubin, liver enzymes, alkaline phosphatase, LDH, and kidney function
You will not qualify if you...
- Patients with metastatic colorectal cancer initially resectable by surgery, radiofrequency, or SBRT
- Diagnosed with MSI-H or dMMR by PCR or immunohistochemistry
- Hypersensitivity to any study treatments
- Received oxaliplatin and fluorouracil adjuvant chemotherapy within 12 months before the study
- Failed one or more palliative chemotherapy regimens
- Uncontrolled hepatitis B virus infection
- Peripheral neuropathy grade 2 or higher
- Neurological or psychiatric disorders affecting cognition
- Uncontrolled central nervous system metastases
- History of enteritis, chronic diarrhea, or recurrent bowel obstruction
- Uncontrolled bleeding or bowel perforation
- Serious uncontrolled diseases within 6 months such as unstable angina, recent heart attack, or stroke
- Pregnant or breastfeeding women or those not using adequate contraception
- History of other cancers without at least 5 years disease-free survival
- Currently receiving other anti-cancer treatments or participating in other clinical trials
- Psychological, family, or social reasons preventing study compliance
- Other serious diseases deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
X
Xiaofen Li, 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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