Gastric Cancer Clinical Trial
Official title:
A Phase II Multicenter, Randomized, Double-blind Study of Apatinib Combined With Paclitaxol Versus Placebo With Paclitaxol as Second Line Therapy for Advanced Gastric / Esophagogastric Junction Adenocarcinoma With Peritoneal Metastasis.
This multicenter, randomized, double-blind study will evaluate the efficacy and safety of
apatinib combined with paclitaxol versus placebo combined with paclitaxol in advanced
gastric cancer or gastroesophageal junction carcinoma patients with peritoneal metastasis.
Patients will be randomized to one treatment arm: Arm A: apatinib 500mg qd, Paclitaxol
80mg/m2, d1, d8, d15,every 4 weeks ; Arm B: placebo 500mg qd, Paclitaxol 80mg/m2, d1, d8,
d15,every 4 weeks ; Tumor assessment will be done every 8 weeks according to RECIST 1.1. The
primary endpoint is progression free survival (PFS).
Gastric cancer is the second most common cause of cancerā€‘related deaths worldwide, and most
patients are diagnozed at advanced stage in China. Peritoneal metastasis is the most common
metastatic site. For gastric cancer patients with peritoneal metastasis, chemotherapy can
bring survival benefit versus best sportive care. Paclitaxol is the standard second line
chemotherapy for advanced gastric cancer patients.
Apatinib mesylate is a small-molecule vascular endothelial growth factor receptor-2
(VEGFR-2) tyrosine kinase inhibitor (TKI). It has been approved as third-line treatment for
patients with advanced gastric adenocarcinoma in China.
This multicenter, randomized, double-blind study will evaluate the efficacy and safety of
apatinib combined with paclitaxol versus placebo combined with paclitaxol in advanced
gastric cancer or gastroesophageal junction carcinoma patients with peritoneal metastasis.
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