NCT03020979

A Clinical Trial With Apatinib for Subjects With Refractory Malignant Ascites

A Phase II, Single-Arm, Open-Label, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Apatinib in Patients With Refractory Malignant Ascites

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: The First Affiliated Hospital of Bengbu Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The study is to investigate the efficacy and safety of apatinib in patients with refractory malignant ascites. A total of 120 patients with performance status 0-2 were enrolled in this study and 500mg apatinib tablets were administered orally, once daily until disease progression or intolerable toxicity or patients withdrawal of consent.

Conditions

• Malignant Ascites
• Apatinib

Interventions

Type	Name	Description
DRUG	Apatinib	Patients will take 500mg apatinib daily orally.

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-12-01
• Completion: 2019-12-01
• First posted: 2017-01-13
• Last updated: 2017-05-31

Locations

1 site across 1 country: China