Actively Recruiting
FOLFOX Via HAI Plus Intravenous Irinotecan With or Without Bevacizumab Versus Systemic FOLFOXIRI With or Without Bevacizumab in Initially Unresectable RAS-mutated CRLM Patients
Led by Sun Yat-sen University · Updated on 2025-05-30
194
Participants Needed
1
Research Sites
230 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This prospective, randomized, controlled clinical study aims to evaluate the objective remission rate of FOLFOX hepatic artery infusion chemotherapy (HAI) in combination with systemic irinotecan with or without bevacizumab versus systemic intravenous FOLFOXIRI with or without bevacizumab in initially unresectable RAS-mutated colorectal cancer patients with liver metastases.
CONDITIONS
Official Title
FOLFOX Via HAI Plus Intravenous Irinotecan With or Without Bevacizumab Versus Systemic FOLFOXIRI With or Without Bevacizumab in Initially Unresectable RAS-mutated CRLM Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed colorectal adenocarcinoma
- Liver metastases confirmed by imaging or pathology
- Liver metastases determined unresectable by multidisciplinary team based on specific criteria
- Presence of mutated RAS and BrafV600E genes
- No prior treatment for liver metastases including chemotherapy, surgery, radiotherapy, TACE, or targeted therapy
- No confirmed extrahepatic metastases (except small lung or lymph node lesions less than 10 mm that are difficult to identify)
- Normal blood cell counts (platelets >90x10^9/L; white blood cells >3x10^9/L; neutrophils >1.5x10^9/L)
- Serum bilirubin ≤1.5 times upper limit of normal; transaminases ≤5 times upper limit of normal
- No ascites, normal blood clotting, albumin ≥35 g/L
- Liver function classified as Child-Pugh grade A
- Serum creatinine below upper limit of normal or creatinine clearance >50 ml/min
- Eastern Cooperative Oncology Group (ECOG) score 0-1
- Life expectancy greater than 3 months
- Signed informed consent
You will not qualify if you...
- Any extrahepatic metastases or primary tumor not suitable for complete surgical removal
- Liver metastases developing within 1 year after finishing prior chemotherapy with FOLFOX or XELOX
- Severe arterial embolism or ascites
- Bleeding disorders or coagulation problems
- Hypertensive crisis or hypertensive encephalopathy
- Severe uncontrolled infections or diabetes
- Significant cardiovascular diseases including recent stroke or heart attack, uncontrolled hypertension, unstable angina, heart failure, or arrhythmias needing medication
- Central nervous system diseases such as brain tumors, epilepsy not controlled by standard therapy, brain metastases, or history of stroke
- Previous cancer within last 5 years except certain skin or cervical cancers
- Use of investigational drugs within 28 days before study
- Remaining side effects from prior chemotherapy like severe peripheral neuropathy
- Known allergy to study drugs
- Women or men of childbearing potential not using effective contraception
- Unable or unwilling to follow study procedures
- Any other medical conditions or findings that may increase risk from study treatments or complications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
L
Li Yuhong
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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