A Phase II Study to Evaluate the Efficacy and Safety of GT90001 in Combination with Nivolumab as a Second-line Treatment in Subjects with Advanced Hepatocellular Carcinoma

Brief description of study

The purpose of the study is to examine and assess the antitumor activities of Nivolumab in combination with GT90001 or Nivolumab alone in subjects with advanced hepatocellular carcinoma (aHCC) who had progressed after or intolerant to first-line treatment. We want to evaluate the efficacy of GT90001 in combination with Nivolumab compared with Nivolumab in patients with advanced Hepatocellular Carcinoma (aHCC) who had progressed after or intolerant to first-line treatment with a tyrosine kinase inhibitor. We also want to evaluate the efficacy of GT90001 in combination with Nivolumab in patients with aHCC who had progressed after or intolerant to first-line treatment of Atezolizumab combined with Bevacizumab. The study drug and combination are investigational, which means that the study drug and combination have not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this combination in the current trial.


Clinical Study Identifier: s21-00779
ClinicalTrials.gov Identifier: NCT05178043


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