Phase I Trial of Intraperitoneal Bevacizumab in Refractory Malignant Ascites

Sponsor
Peking University
Study ID
NCT01852409
Phase
PHASE1
Status
Unknown

Conditions

  • Refractory Malignant Ascites

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Malignant ascites often has a profound impact on the quality of life of cancer patients. Current treatments,including dietary, medical, and procedural are often temporary and unsatisfactory options in patients approaching the end of life. Intraperitoneal bevacizumab for the palliation of malignant ascites might be a novel choice for refractory malignant ascites.

Key Dates

First listed
May 13, 2013
Start date
May 31, 2013
Status verified
May 2013
Primary completion
Jun 30, 2015
Completion
Jun 30, 2015

Study Design

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

Arms

  • Experimental: bevacizumab
    The study evaluate 4 dose level of bevacizumab:2.5mg /kg;5 mg /kg;7.5mg /kg; 1.25mg /kg;

Primary Outcome Measure

adverse events [ Time Frame: during the treatment in the hospital,an expected average of 1 week ]

Central Contacts