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Table 2 Baseline assessment

From: Ipilimumab or FOLFOX with Nivolumab and Trastuzumab in previously untreated HER2-positive locally advanced or metastatic EsophagoGastric Adenocarcinoma - the randomized phase 2 INTEGA trial (AIO STO 0217)

 • Review of inclusion and exclusion criteria

 • Medical and medication history, physical examination including height, weight, vital signs (blood pressure, heart rate, respiratory rate, body temperature), oxygen saturation, ECOG-performance status

 • Laboratory Tests:

  o Hematology panel: hemoglobin, platelets, white blood cell (WBC) count and WBC differential (neutrophils, lymphocytes)

  o Chemistry panel: sodium, potassium, calcium, magnesium, creatinine, urea, total bilirubin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total protein, albumin, LDH, glucose, amylase, lipase

  o Free T3/T4 and TSH

  o Coagulation: INR, aPTT

  o CA 72–4 (CEA, CA 19–9 optional)

  o Hepatitis B/C screening test (HBsAg, anti-HBc, anti-HBs, anti-HCV)

  o HIV screening test (HIV 1/2 antigen/antibody test)

  o Pregnancy test for women of childbearing potential within 24 h prior to start of the treatment

 • Blood draw for translational research

 • Obtain paraffin-embedded tumor-tissue for translational research

 • Echocardiography and ECG

 • Quality of life assessment (EORTC QLQ-C30 and STO-22)

 • Disease assessment by radiological imaging of the chest, abdomen, pelvis and all other sites of disease (CT/MRI-scan)