Chemoembolization (Lifepearls-Irinotecan) in Patients With Colorectal Cancer and Metastatic Disease

Inclusion Criteria:

• Patients aged ≥ 18 years.

• Patients with colorectal cancer and exclusive liver metastases with poor prognosticcriteria,> 3 lesions and / or size> 5 cm. Patients with a diagnosis of livermetastases with synchronous presentation or with a disease-free interval may beincluded. If the primary tumor has not been resected, it must be clinically stable.

• Measurable disease following RECIST version 1.1 criteria

• Adequate bone marrow function, according to:

1. Hemoglobin ≥ 9.0 g / dl (patients with hemoglobin <9 g / dl can be transfusedbefore inclusion in the study

2. Platelet count ≥ 100 x 109 / L

3. Absolute Neutrophil Count (ANC) ≥ 1.5x 109 / L

• Adequate liver function, according to:

1. Serum bilirubin ≤ 1.5 x the upper limit of normal (ULN)

2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN.

3. Alkaline phosphatase ≤ 5 x ULN or ≤10 x ULN in the presence of bone metastases

4. Adequate renal function, with creatinine levels <1.5 mg / dL. Blood UreicNitrogen (BUN)> 50 ml / min.

5. Albumin> 3.0 g / dL

• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.

• Patients capable of understanding the information and giving their written informedconsent to participate in the study

• Women of childbearing potential must commit to sexual abstinence or use of barriercontraceptive methods during the study and must have a negative pregnancy test.

Exclusion Criteria:

• Extension of the disease> 50% of the liver parenchyma (evaluated by CT performedwithin the month prior to inclusion)

• Previous chemotherapy treatment for metastatic colorectal cancer

• Clinically significant cardiovascular diseases: cerebrovascular accident / stroke (≤ 6 months before inclusion in the trial), myocardial infarction (≤ 6 months beforeinclusion in the trial), unstable angina, uncontrolled hypertension, congestiveheart failure of New York Heart Association (NYHA) grade II or higher or severecardiac arrhythmia.

• History of malignancy in the last three years, except for basal cell carcinoma ofthe skin or carcinoma in situ of the cervix treated appropriately.

• Altered coagulation (Quick> 50%)

• Patients with active infectious processes

• Patients with any of the contraindications specified in the technical data sheet ofthe study drug or with allergies to some of the drugs used

• Pregnant or lactating patients

• Portal thrombosis

• Severe portal hypertension

• Extrahepatic metastases