A Study of Systemic Chemotherapy With/Without HAI in Patients With Initially Unresectable Colorectal Liver Metastasis

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.

Age

18–70

Sex

ALL

Healthy volunteers

Not accepted

You may be eligible if

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

You may not be if

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

A Study of Systemic Chemotherapy With/Without HAI in Patients With Initially Unresectable Colorectal Liver Metastasis

What this study is about

A Study of Systemic Chemotherapy With/Without HAI in Patients With Initially Unresectable Colorectal Liver Metastasis

What this study is about