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

Korábbi kezelés

• Extension of the disease> 50% of the liver parenchyma (evaluated by CT performed within 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 before inclusion in the trial), unstable angina, uncontrolled hypertension, congestive heart failure of New York Heart Association (NYHA) grade II or higher or severe cardiac arrhythmia.

Más betegség

• History of malignancy in the last three years, except for basal cell carcinoma of the skin or carcinoma in situ of the cervix treated appropriately.
• Patients with any of the contraindications specified in the technical data sheet of the study drug or with allergies to some of the drugs used
• Portal thrombosis
• Severe portal hypertension

Egyéb

• Altered coagulation (Quick> 50%)
• Patients with active infectious processes
• Pregnant or lactating patients
• Extrahepatic metastases

• Patients aged ≥ 18 years.
• Patients with colorectal cancer and exclusive liver metastases with poor prognostic criteria,> 3 lesions and / or size> 5 cm. Patients with a diagnosis of liver metastases with synchronous presentation or with a disease-free interval may be included. 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:
  • Hemoglobin ≥ 9.0 g / dl (patients with hemoglobin <9 g / dl can be transfused before inclusion in the study
  • Platelet count ≥ 100 x 109 / L
  • Absolute Neutrophil Count (ANC) ≥ 1.5x 109 / L
• Adequate liver function, according to:
  • Serum bilirubin ≤ 1.5 x the upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN.
  • Alkaline phosphatase ≤ 5 x ULN or ≤10 x ULN in the presence of bone metastases
  • Adequate renal function, with creatinine levels <1.5 mg / dL. Blood Ureic Nitrogen (BUN)> 50 ml / min.
  • Albumin> 3.0 g / dL
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
• Patients capable of understanding the information and giving their written informed consent to participate in the study
• Women of childbearing potential must commit to sexual abstinence or use of barrier contraceptive methods during the study and must have a negative pregnancy test.