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Gastrointestinal Diseases

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Apatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Apatinib: 500mg, po, qd, every 4 weeks Paclitaxol: 80mg/m2, d1, d8, d15, every 4 weeks

Placebo: 500mg, po, qd, every 4 weeks Paclitaxol: 80mg/m2, d1, d8, d15, every 4 weeks

Apatinib 500mg, po, qd, every 4 weeks Paclitaxol: 80mg/m2, d1, d8, d15, every 4 weeks

Placebos

Wei Wang

Fenghua Wang, MD, PhD

Miao-Zhen Qiu, MD, PhD

Rui-Hua Xu, MD, PhD

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.

Multicenters ramdomized double-blind phase II study.

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

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.

The time from randomize to progression or death

The rate of complete response and partial response according to RECIST guidelines

The rate of complete response , partial response and stable disease according to RECIST guidelines

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Apatinib Combined With Paclitaxol as Second Line Therapy for Advanced Gastric Cancer.	NCT03144843	Gastric Cancer	Apatinib Placebos	18 Years - 75 Years	Sun Yat-sen University
Apatinib Combined With Paclitaxol as Second Line Therapy for Advanced Gastric Cancer.	NCT03144843	Gastric Cancer	Apatinib Placebos	18 Years - 75 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for paclitaxol

Every month we try and update this database with for paclitaxol cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for paclitaxol

Every month we try and update this database with for paclitaxol cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for paclitaxol cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.