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Spots Global Cancer Trial Database for Apatinib Combined With Paclitaxol as Second Line Therapy for Advanced Gastric Cancer.

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Trial Identification

Brief Title: Apatinib Combined With Paclitaxol as Second Line Therapy for Advanced Gastric Cancer.

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.

Study ID: NCT03144843

Conditions

Gastric Cancer

Interventions

Apatinib
Placebos

Study Description

Brief Summary: 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).

Detailed Description: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Foshan people's Hospital, Foshan, Guangdong, China

Cancer center of Sun Yat-sen University, Guangzhou, Guangdong, China

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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