{"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"description":"Twelve immunomodulatory cytokines were selected based on previous a feasibility study and detected using multiplex Luminex bead assays from patient's plasma. One cytokines, HGF, was eliminated due to extremely low expression. Three representative cytokines, TGF-beta 1, IL-8 and VEGF were to be evaluated for association with survival due to clustering.","groups":[{"description":"Patients were to receive cetuximab 400 mg/m\\^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.","id":"OG000","title":"Arm A - Cetuximab"},{"description":"Patients received cetuximab 400 mg/m\\^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.","id":"OG001","title":"Arm B - Cetuximab and Sorafenib Tosylate"}],"populationDescription":"Data were not collected due to an insufficient amount of tumor tissue available.","reportingStatus":"POSTED","timeFrame":"Pre-therapy, up to about 42 months (follow-up for overall survival)","title":"Overall Survival Associated With Immunomodulatory Cytokines","type":"SECONDARY"}