The aim of this study is the safety and efficacy of Bevacizumab plus allogeneic natural killer (NK) immunotherapy to many kinds of recurrent solid tumors.
By enrolling patients with recurrent solid tumors adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using Bevacizumab and NK cells. The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
7.5 mg/kg, i.v, once every 3 weeks (continuous)
Each treatment: 8\~10 billion cells in all, transfusion in 3 times, i.v.
Fuda cancer institute of Fuda cancer hospital
Guangzhou, Guangdong, China
PFS
PFS was defined as the interval between treatment initiation and local relapse
Time frame: 1 year
OS
OS was calculated as the interval from treatment initiation to death.
Time frame: 3 years
Tumor size
The tumor responses of the enrolled patients were assessed by CT in accordance with RECIST v1.1.Institute Common Terminology Criteria for Adverse Events (v4.0).
Time frame: 3 months
CTC
The absolute number of CD45-CK+ CD326+ cells was used to quantitate the CTC levels.
Time frame: 3 months
PD-1
Peripheral blood (6 mL) was obtained from healthy donors and patients before treatment and 90 days after treatment for the detection of PD-1
Time frame: 3 months
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