A placebo versus study medication trial study for verification of improving survival in metastatic colorectal cancer patients.

Interventions: Clinical safety/efficacy, randomized, double-blinded, phase 3 trial of placebo versus xilonix. It will be included 800 patients of both sexes aged 18 years or older. Patients will receive 1 dose every 2 weeks of placebo (1/3 of patients) or of 7,5 mg/kg of the human monoclonal antibody anti interleukin 1a (also named MABp1 or xilonix) that will be administered intravenously for as long as the patient is beneficiating or until he/she reaches any of the protocol discontinuation criteria, i.e: pregnancy, consent withdrawal, disease progression, adverse event that justifies the patient withdrawal or study termination by the sponsor.;Drug;Biological/vaccine
Primary outcome(s): Overall survival will be the primary endpoint of this study survival time will be defined as the duration from the date of randomization until death or censor date.
Study Design: Clinical trial of efficacy, randomized, double-blinded, double arm and placebo-controlled (1:2), phase 3