Gastric Cancer Clinical Trial
Official title:
A Phase II Randomized Trial of Telatinib in Combination With Capecitabine/Oxaliplatin Versus Capecitabine/Oxaliplatin as First-Line Therapy in Patients With HER2-negative Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction
The purpose of the trial is to compare the combination regimen of Telatinib and Capecitabine and Oxaliplatin vs. Capecitabine and Oxaplatin to explore superiority of the Telatinib combination in terms of progression-free survival (PFS) in patients previously untreated for advanced HER2 negative advanced gastric or Gastroesophageal Junction adenocarcinoma.
This trial is a Phase 2, prospective, double-blind, randomized, comparative, multicenter trial in patients with advanced HER2 negative adenocarcinoma of the stomach or Gastroesophageal Junction which has progressed after resection and adjuvant or neoadjuvant therapy, or is unresectable or metastatic at time of first diagnosis. a total of approximately 90 patients will be enrolled and randomized into Telatinib combined with Capecitabine and Oxaliplatin or chemotherapy combined with placebo. All patients will be treated until progressive disease (radiologically documented or symptomatic deterioration) or the occurrence of unacceptable toxicity, withdrawal of consent or investigator's judgment. ;
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