Vaccination With Autologous Dendritic Cells Loaded With Autologous Tumour Homogenate After Curative Resection for Stage IV Colorectal Cancer.

Single-arm, monocentric trial to assess safety and immunological efficacy of adjuvant vaccination with autologous dendritic cells loaded with autologous tumour homogenate after curative resection for stage IV colorectal cancer

Inclusion Criteria: 1. Patients must have histologically confirmed stage IV colorectal cancer surgically treated with radical intent. 2. The autologous surgical specimen must have been collected and sent to the Somatic Cell Therapy Lab of Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST IRCCS) and must fulfil all the acceptance criteria prescribed by the Good Manufacturing practise (GMP) procedures. 3. The patient must be disease-free, as assessed by CT scan or MRI of the chest, abdomen, pelvis performed within 60 days before enrolment. If the resected lesions had occurred in other sites, these must be also included in the baseline CT scan and in all the subsequent evaluations. 4. The patient must have recovered (grade 1 or less by CTCAE 4.0) from all the adverse events related to previous surgery. 5. Age \>18 years. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 7. Patient must have acceptable organ function, defined as: 1. Haemoglobin \>10 g/dl 2. White blood cells ≥4000/μl. 3. Absolute neutrophil count \>1500/μl. 4. Platelets ≥100000/μl. 5. aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT) \