Actively Recruiting
Cetuximab Plus Irinotecan in Patients With NeoRAS Wild-type Metastatic Colorectal Cancer In Third-line Therapy
Led by Sun Yat-sen University · Updated on 2023-08-31
54
Participants Needed
1
Research Sites
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cetuximab Plus Irinotecan in Patients With NeoRAS Wild-type Metastatic Colorectal Cancer In Third-line Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed colorectal adenocarcinoma
- Initial RAS mutant, BRAF wild-type left-sided metastatic colorectal cancer
- Disease progression after standard first-line and second-line therapy with fluorouracil compounds, oxaliplatin, and irinotecan
- Tumor progression within 3 months during or after irinotecan-containing regimen
- Blood-based circulating tumor DNA test shows RAS and BRAF genes are wild-type after second-line therapy progression
- At least one measurable lesion according to RECIST v1.1 criteria
- Normal blood counts: platelets > 90 × 10^9/L; leukocytes > 3 × 10^9/L; neutrophils > 1.5 × 10^9/L; hemoglobin > 8.0 g/100 ml
- Serum bilirubin ≤ 1.5 times upper limit of normal and transaminases ≤ 5 times upper limit of normal
- Normal coagulation and albumin ≥ 35 g/L
- Liver function classified as Child-Pugh Class A
- Serum creatinine < 1.5 times upper limit of normal or creatinine clearance ≥ 50 ml/min
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score 0-2
- Life expectancy greater than 3 months
- Signed informed consent
- Willing and able to be followed up until death, end of study, or study termination
You will not qualify if you...
- Primary right-sided metastatic colorectal cancer
- Deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer
- Initial RAS wild-type or BRAF mutant metastatic colorectal cancer
- Blood-based circulating tumor DNA test showing RAS or BRAF mutation after second-line therapy
- Serious arterial embolism or ascites
- Serious bleeding tendency or coagulation disorders
- Uncontrolled systemic complications such as infection or diabetes
- Significant cardiovascular disease including recent stroke, myocardial infarction, unstable angina, congestive heart failure (NYHA class 2-4), or cardiac arrhythmia requiring medication
- History or evidence of central nervous system disease including brain tumor, uncontrolled epilepsy, brain metastases, or stroke
- Other malignancies within past 5 years except select skin, cervical, or thyroid cancers after surgery
- Hypersensitivity to any study drug
- Pregnant or breastfeeding women
- Women of childbearing potential or men not using effective non-hormonal contraception
- Unable or unwilling to follow study protocol
- Any other disease or dysfunction from metastases that contraindicates study drug use or increases risk of treatment complications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer center of Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
R
Ruihua Xu, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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