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A Phase II study of TAS 102 in Combination with Ramucirumab in Advanced, Refractory Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
This is a single institutional phase II single arm two-stage design trial using the combination of TAS 102 and ramucirumab in advanced, refractory gastric or GEJ adenocarcinoma.
Primary Objective To determine the 6 month overall survival in patients with advanced, refractory gastric or gastroesophageal junction (GEJ) adenocarcinoma receiving TAS 102 in combination with ramucirumab. Secondary Objectives 1. To determine the frequency and severity of adverse events and tolerability of TAS 102 plus ramucirumab in patients with advanced, refractory gastric or GEJ adenocarcinoma 2. To determine the objective response rate of TAS 102 in combination with ramucirumab based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 3. To determine the progression free survival in patients with advanced, refractory gastric or GEJ adenocarcinoma receiving TAS 102 in combination with ramucirumab. Exploratory Objectives 1. To evaluate potential correlations between blood biomarkers and clinical outcome using a multiplex assay evaluating circulating angiogenic biomarkers
IMC-1121B (Ramucirumab); Ramucirumab (); TAS 102 ()