Actively Recruiting
Conversion Treatment With Hepatic Arterial Infusion of Oxaliplatin, Leucovorin and Fluorouracil Plus Intravenous Bevacizumab or Cetuximab for Initially Unresectable Colorectal Liver Metastasis: A Prospective Study
Led by Tongji Hospital · Updated on 2025-05-25
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Colorectal cancer often leads to liver metastases, affecting about half of patients and significantly shortening survival. Complete surgical removal of liver metastases can improve outcomes, but most patients initially have tumors that cannot be removed. This study is a Phase 2 trial that evaluates whether combining hepatic arterial infusion chemotherapy with targeted drugs bevacizumab or cetuximab can increase the chance of making previously unresectable colorectal liver metastases removable, aiming to improve long-term survival. Patients in this study receive a combination treatment called FOLFOX-HAIC, which delivers chemotherapy drugs oxaliplatin, leucovorin, and 5-fluorouracil directly into the liver artery. Alongside this, patients receive intravenous bevacizumab or cetuximab based on tumor characteristics. The infusion procedure involves catheter insertion through the femoral artery to target liver tumors. If tumors become operable, liver surgery may be performed. Treatment cycles are repeated approximately every three weeks. Participants will be monitored for tumor response, safety, and conversion to surgery over 180 days and up to 12 months. Evaluations include imaging to measure tumor size, blood tests to assess organ function, and assessments of treatment side effects. The main goal is to see how many patients can proceed to liver surgery. Long-term follow-up will assess survival outcomes and overall safety throughout the study period ending in 2030.
CONDITIONS
Brief Title
FOLFOX-HAIC as Conversion Treatment for Initially Unresectable Colorectal Liver Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- No history of other malignant diseases
- Diagnosed with colorectal liver metastasis confirmed by pathology
- Refuse or progress in prior systemic treatment
- At least one measurable liver lesion
- Left ventricular ejection fraction 45% or higher
- Forced expiratory volume in one second/forced vital capacity ratio 60% or higher
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Child-Pugh class A liver function
- Adequate organ function including WBC ≥3.0×10^9/L, neutrophils ≥1.5×10^9/L, platelets ≥75×10^9/L, total bilirubin ≤30 µmol/L, ALT and AST ≤200 U/L, and creatinine ≤150 µmol/L
You will not qualify if you...
- Presence of extra-hepatic metastasis confirmed by imaging
- Inability to tolerate chemotherapy, anesthesia, or surgery
- Allergy or previous intolerance to oxaliplatin, leucovorin, 5-fluorouracil, bevacizumab, or cetuximab
- Tumor spread in the abdomen
- Cerebral infarction, cerebral hemorrhage, gastrointestinal hemorrhage or perforation within 6 months
- Coagulation disorders or gastrointestinal ulcers
- Primary tumor not completely resectable
- Prior treatment of colorectal liver metastasis with resection, ablation, or radiation
- Incomplete clinical or follow-up data
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive hepatic arterial infusion chemotherapy (FOLFOX-HAIC) combined with either Bevacizumab or Cetuximab to treat initially unresectable colorectal liver metastasis.
Repeated catheterizations and chemotherapy infusions approximately every 3 weeks; Bevacizumab given once every 3 weeks or Cetuximab given weekly
Duration - Up to 12 months after treatment
Participants are monitored for treatment safety, tumor response, and potential conversion to liver resection.
Regular assessments during treatment and up to 12 months post-treatment
Trial Site Locations
Total: 1 location
1
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
Z
Zhang Bi Xiang
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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