A Clinical Trial With Apatinib for Subjects With Refractory Malignant Ascites

Sponsor
The First Affiliated Hospital of Bengbu Medical University
Study ID
NCT03020979
Phase
PHASE2
Status
Unknown

Conditions

  • Apatinib
  • Malignant Ascites

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Apatinib — DRUG
    Patients will take 500mg apatinib daily orally.

Study Details

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.

Key Dates

Start date
Jan 31, 2017
Status verified
May 2017
Primary completion
Dec 31, 2018
Completion
Dec 31, 2019

Study Design

Enrollment
120 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 500mg apatinib
    Patients will receive 500mg of apatinib tablet orally, once daily.

Primary Outcome Measure

The repeat paracentesis response rate (proportion of subjects who have a doubling of baseline time to repeat paracentesis) [ Time Frame: 12 weeks after initiation of study treatment ]

Central Contacts

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