Combining chemotherapy with hepatic arterial infusion for colorectal liver metastasis
Systemic Chemotherapy With or Without Hepatic Arterial Infusion With Floxuridine in Patients With Initially Unresectable Colorectal Liver Metastasis: A Prospective, Randomised, Controlled Study
This study is testing if combining a specific type of chemotherapy with a targeted liver treatment can help people with colorectal cancer that has spread to the liver have better surgery outcomes and live longer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 142 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT02102789 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of systemic chemotherapy combined with hepatic arterial infusion (HAI) using floxuridine and dexamethasone in patients with initially unresectable colorectal liver metastasis. The primary goal is to determine if this combination can increase the rate of complete surgical resection (R0) and improve overall survival rates. The study is designed as a Phase 3 interventional trial, building on previous findings that suggest this approach may be beneficial. Participants will be closely monitored for treatment efficacy and safety throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with histologically confirmed colorectal adenocarcinoma and initially unresectable liver metastasis.
Not a fit: Patients with extra-hepatic metastasis or those who have received prior treatment for liver metastasis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve surgical outcomes and survival rates for patients with colorectal liver metastasis.
How similar studies have performed: Previous studies have shown promising results with similar approaches, but this Phase 3 trial aims to provide high-level evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: 18-70 years old * Histologically confirmed colorectal adenocarcinoma * Radiologically or pathologically confirmed diagnosis of colorectal liver metastasis * Initially unresectable colorectal liver metastasis confirmed by the multidisciplinary team (MDT) * With no prior treatment for liver metastasis, including chemotherapy, operation, radiotherapy, transcatheter hepatic arterial chemoembolization (TACE) and targeted therapy * Without extra-hepatic metastasis confirmed by CT, MRI or PET/CT (if necessary) scanning * With adequate bone marrow function: platelets ≥ 90 x 109/L; white blood cells ≥ 3×109/L; absolute neutrophil count (ANC) ≥ 1.5 x 109/L * Serum bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 5 x ULN * Patient has no ascites and with adequate blood coagulation function, albumin ≥ 35 g/L * Grade A level of Child-Push Liver Function * Creatinine ≤ 1× ULN, or Calculated Creatinine Clearance \>50ml/min （Cockcroft-Gault Equation） * ECOG performance status of 0-2 * Life expectancy ≥ 3 months * Not appropriate for anti-EGFR or any other targeted therapy (with KRAS mutation or could not afford it) * Patients have provided a signed Informed Consent Form * With good compliance Exclusion Criteria: * With any extra-hepatic metastasis and/or primary tumor recurrence * Severe arterial embolism or ascites * With hemorrhagic tendency or coagulation disorders * Hypertensive crisis or hypertensive encephalopathy * Severe and uncontrolled systemic complications such as infections or diabetes * Serious cardiovascular diseases such as cerebrovascular accident (within 6 months before enrollment), myocardial infarction (within 6 months before enrollment), uncontrolled hypertension even with appropriate drug intervention, unstable angina pectoris, congestive heart failure (NYHA 2-4 degree), arrhythmia that needs medication intervention * Patient who has suffered from central nervous system diseases such as primary brain tumor, uncontrolled epilepsy even with standard treatment, any brain metastasis or stroke * Patient who has a concurrent malignancy or has a malignancy within 5 years before study enrollment, (with the exception of radically resected skin basal cell carcinoma or cervical carcinoma in situ) * Patient who has received any investigational antineoplastic agent within 28 days before the enrollment * Any residual toxicity from prior chemotherapy (with the exception of alopecia), such as grade 2 or more sensory peripheral neuropathy (NCI CTC v3.0), oxaliplatin-based regimen will not be considered * Patient who is allergic to oxaliplatin, leucovorin, 5-Fluorouracil, floxuridine or dexamethasone * Pregnant or lactating women * Patient who does not use or refuses to take any appropriate contraceptive measures (intrauterine contraceptive ring, barrier contraception combined with spermicidal gel or sterilization operation), including women of childbearing age (within 2 years after the last menstrual period) and men who are with possible fertility * Unable or unwilling to comply with the research plan * The existence of any other disease, dysfunction caused by metastatic lesions, or suspicious disease found on the regular examination, which indicating contraindications to the use of study drugs or may bring high risks of treatment related complications
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Yu-hong Li, MD, Ph D — Sun Yat-sen University
- Study coordinator: Yu-hong Li, MD, Ph D
- Email: liyh@sysucc.org.cn
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.