Recent studies and our experience have proved the efficacy and safety of systemic
chemotherapy combined with hepatic arterial infusion (HAI) with floxuridine and dexamethasone
in patients with initially unresectable colorectal liver metastasis. However, most of them
are retrospective studies, phase I or II clinical researches, which could not provide
high-level evidence. Therefore, we designed this study to determine whether systemic
chemotherapy combined with HAI can increase the complete resection rate (R0) and improve the
overall survival in patients with initially unresectable colorectal liver metastasis.
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
