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 cancer-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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
110
Foshan people's Hospital
Foshan, Guangdong, China
RECRUITINGCancer center of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGProgression-free survival (PFS)
The time from randomize to progression or death
Time frame: Approximately 1 year
Overall survival (OS)
The time from randomize to death
Time frame: Approximately 3 years
Objective response rate (ORR)
The rate of complete response and partial response according to RECIST guidelines
Time frame: Approximately 1 year
Disease control rate(DCR)
The rate of complete response , partial response and stable disease according to RECIST guidelines
Time frame: Approximately 1 year
Safety (incidence of adverse events) [
Incidence of adverse events
Time frame: Approximately 1 year
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