Blood-borne Assessment of Stromal activation in esophageAL adenocarcinoma to guide tocilizumab Therapy: a randomized phase II proof-of-concept study (BASALT)

Lab values

• Past (within 5 years) or current history of malignancy other than entry diagnosis interfering with prognosis of esophageal cancer, not including superficial and adequately treated skin and cervical malignancies. - Previous chemotherapy, radiotherapy and/or treatment with IL-6 receptor blockers for esophageal cancer. - Previous radiation to the mediastinum precluding full dose radiation of the currently present esophageal tumor. - Previous chemotherapy and/or treatment with targeted agents and/or IL-6 receptor blockers for other forms of cancer within the last six months. - Invasion of the tracheobronchial tree or presence of tracheoesophageal fistula. - T1N0 tumors or in situ carcinoma. - Pregnancy (positive serum pregnancy test), planning to become pregnant, and lactation. - Patient (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment. - Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) precluding major surgery. - Pulmonary fibrosis and/or severely impaired lung function precluding major surgery. - Serious underlying medical condition which would impair the ability of the patient to receive the planned treatment, including prior allergic reactions to drugs containing Cremophor, such as teniposide or cyclosporine. - Dementia or altered mental status that would prohibit the understanding and giving of informed consent. - Inadequate caloric- and/or fluid intake despite consultation of a dietician and/or tube feeding. - Requires systemic treatment with IL6 receptor blockers or IL-6 antagonists, TNF-alpha blockers or other biologicals within the last six months before the first dose of trial treatment. - Has evidence of interstitial lung disease or active, non-infectious pneumonitis. - Has an active infection requiring systemic therapy which has not resolved 3 days (simple infection such as cystitis) to 7 days (severe infection such as pyelonephritis) prior to the first dose of trial treatment. - Has a total cholesterol > 6.5 mmol/L despite adequate treatment with lipid-lowering agents. - Has evidence of (latent) tuberculosis infection in patient history. - Receiving a live or live weakened vaccine during treatment with tocilizumab. - Has evidence of acute or chronic infection with hepatitis B. - Patients with prior allogeneic stem cell or solid organ transplantation. - Pre-existing motor or sensory neurotoxicity greater than WHO grade 1. - Known allergy for tocilizumab or one of its excipients (sucrose, polysorbate 80, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dehydrate).

• Histologically proven adenocarcinoma of the esophagus or gastroesophageal junction or high grade dysplasia with high clinical suspicion for adenocarcinoma which will be treated accordingly. - Surgical resectability ( 60 ml/min. - If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative pregnancy test (urine or serum; beta-human chorionic gonadotropin (β-hCG)) documented prior to the first administration of study drug. If sexually active, the patient must agree to use contraception considered adequate and appropriate by the Investigator during the period of administration of study drug and after the end of treatment as recommended. - Written, voluntary informed consent. - Patients must be accessible to follow up and management in the treatment center.