Table 1.
Inclusion and Exclusion Criteria.
| Inclusion Criteria | Exclusion Criteria |
|---|---|
| Patients of both sex aged ≥18 years | Age less than 18 years |
| Histological confirmation of rectal adenocarcinoma | Patients with neoplasia more than 12 cm from the anal margin |
| Patients undergoing neoadjuvant treatment for locally advanced tumor of the rectum with confirmed major clinical response after neoadjuvant treatment | Patients with stable disease or disease progression after neoadjuvant treatment |
| Rectal tumor up to 12 cm from the external anal margin | Patients who, for medical reasons, cannot be given bleomycin |
| Patients must be willing to comply with the study protocol and give their informed written consent | Lesions unsuitable for Electrochemotherapy (ECT) (bony invasion, large vessels infiltration, etc.) |
| Patients with an Eastern Cooperative Oncology Group (ECOG) status performance <3 | Acute lung infection |
| Poor lung function symptoms | |
| Severe coagulation disorders | |
| Previous allergic reactions to bleomycin | |
| Previous cumulative bleomycin dose over than 250 mg/m2 | |
| Chronic renal dysfunction (creatinine> 150 µmol/L) | |
| Pregnancy or lactation |