Combination of Chemoradiation With Immunotherapy in Inoperable œsophageal Cancer

Exclusion Criteria

• •Cancer of cervical oesophagus (15 to 19 cm from dental ridge)
• •Known Her2 positive adenocarcinoma
• •Weight loss \> 15 % over the last 3 months without improvement after nutritional support
• •Patient with cardiac dysfunction e.g. symptomatic congestive heart failure, uncontrolled hypertension
• •Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS), hepatitis B or hepatitis C.
• •Any prior treatment for advanced disease including treatment with an anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD-L2, anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA-4) antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
• •Live vaccines within 30 days prior to the first dose of study therapy. Examples of live vaccines include, but are not limited to the following: measles, mumps, rubella, chicken pox, yellow fever, H1N1 flu, rabies, BCG, and typhoid vaccine
• •History of hypersensitivity to study drugs or any excipient (refer to SmPCs for ipilimumab, nivolumab, 5-FU and oxaliplatin)
• •Current participation or treatment with an investigational agent or use of an investigational agent within 4 weeks of the first dose of study treatment
• •Serious comorbidity or life expectancy less than one year
• •Contraindication to chemoradiation therapy
• •Treatment history of radiotherapy
• •Child-Pugh B/C and patients with history of acute or chronic pancreatitis
• •Patient with Type I diabetes mellitus, or skin disorders
• •Known severe systemic autoimmune disease affecting the lungs or the bowel
• •Known contraindication to CT scans with IV contrast
• •Chronic use of immunosuppressive agents and/or systemic corticosteroids or any use in the last 15 days prior to enrollment
• •Active autoimmune disease that has required systemic treatment in past 2 years
• •Autoimmune paraneoplastic syndrome requiring immunosuppressive or dedicated treatment
• •History of any other hematologic or primary solid tumor malignancy, unless in remission for at least 5 years.