A Phase II, Single-Arm, Open-Label, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Apatinib in Patients With Refractory Malignant Ascites
Malignant ascites is a severe complication of many types of human cancer. Animal and clinical analyses have shown that angiogenesis plays a critical role in the formation of malignant ascites. Therefore, drugs such as apatinib that target angiogenesis may control the development of malignant ascites. The study is to evaluate the efficacy and safety of apatinib in patients with refractory malignant ascites.
• Persistent or symptomatic ascites with positive cytology secondary to any histologically confirmed tumor type not amenable to cytoreductive surgery or additional chemotherapy
• Patients may enroll in this study irrespective of previous therapy including diuretics, surgery, chemotherapy, immunotherapy and radiation therapy
• Must have received a minimum of two paracentesis procedures and a trial of diuretic therapy within 60 days of study entry
• Age Restrictions: 18-75 years
• Life Expectancy: 12 weeks or more
• ECOG Performance Status: 0-2
• Able and willing to provide informed consent and comply with study and/or follow-up procedures
• Normal organ and marrow function as defined by: Leukocytes \>/= 3,000/mcL; Absolute neutrophil count \>/= 1,500/mcL; Platelets \>/= 100,000/mcL; Total bilirubin within normal institutional limits; AST (SGOT)/ALT(SGPT) \</= 2.5 X institutional upper limit of normal (ULN); Creatinine within normal institutional limits OR Creatinine clearance \>/+ 60 mL/min for patients with creatinine levels above the institutional normal; Serum Potassium within normal institutional limits; Serum Sodium within normal institutional limits