A Phase 2 interventional study of Apatinib and Placebos in Gastric Cancer, sponsored by Sun Yat-sen University. Status unknown at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-05-09.
Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment
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.
2,851 studies on the registry are indexed under Stomach Neoplasms; 863 are open to participants now.
This study's planned enrollment of 110 is above the median of 67 across 2,095 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Apatinib: 500mg, po, qd, every 4 weeks Paclitaxol: 80mg/m2, d1, d8, d15, every 4 weeks
Drug: Apatinib
Placebo: 500mg, po, qd, every 4 weeks Paclitaxol: 80mg/m2, d1, d8, d15, every 4 weeks
Drug: Placebos
Apatinib 500mg, po, qd, every 4 weeks Paclitaxol: 80mg/m2, d1, d8, d15, every 4 weeks
Also known as: Paclitaxol
Placebo: 500mg, po, qd, every 4 weeks Paclitaxol: 80mg/m2, d1, d8, d15, every 4 weeks
Also known as: Paclitaxol
Progression-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
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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