A Clinical Trial With Apatinib for Subjects With Refractory Malignant Ascites
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital of Bengbu Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients having received anti-angiogenic agents as part of the treatment of their malignancy within 60 days prior to study entry
Current, recent (within 30 days of the first infusion of this study) or planned administration of chemotherapy (including all routes of administration), immunotherapy, biologic therapy, radiation therapy or any other anti-angiogenic therapy (e.g., bevacizumab, other tyrosine kinase inhibitors)
Current, recent (within 30 days of the first infusion of this study), or planned participation in any other experimental drug study
Pregnant women; A serum pregnancy test will be given to females of childbearing potential prior to study enrollment and the participant must agree to use adequate contraception (barrier or hormonal methods) prior to study entry and for the duration of study participation.
Trial design
Design model
Single group
Treatments tested in this trial
Apatinib
DrugPatients will take 500mg apatinib daily orally.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: 500mg apatinibExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 treatmentSecondary outcomes
1
The time to the need for the first repeat abdominal paracentesis after the start of apatinib therapy as compared with historical control data.
Time frame
12 weeks after initiation of study treatment2
The mean number of paracentesis procedures required in each patient over the course of three months.
Time frame
12 weeks after the initiation of study treatment3
The effect of apatinib therapy on quality of life in patients with malignant ascites by using EORTC QLQ-C30 V3.0.
Time frame
12 weeks after the initiation of study treatmentSponsors and contacts
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Source ClinicalTrials.gov