Malignant Solid Tumour
Conditions
Keywords
Vascular Endothelial Growth Factor (VEGF) antibody, solid tumor, NK Immunotherapy
Brief summary
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.
Detailed description
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).
Interventions
DRUGBevacizumab
7.5 mg/kg, i.v, once every 3 weeks (continuous)
BIOLOGICALNK immunotherapy
Each treatment: 8\ 10 billion cells in all, transfusion in 3 times, i.v.
Sponsors
Shenzhen Hank Bioengineering Institute
Fuda Cancer Hospital, Guangzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence * Body tumor 1-6, the maximum tumor length \< 5 cm * KPS ≥ 70, lifespan \> 6 months * Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L
Exclusion criteria
* Patients with cardiac pacemaker * Patients with brain metastasis * Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 1 year | PFS was defined as the interval between treatment initiation and local relapse |
| OS | 3 years | OS was calculated as the interval from treatment initiation to death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor size | 3 months | 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). |
| CTC | 3 months | The absolute number of CD45-CK+ CD326+ cells was used to quantitate the CTC levels. |
| PD-1 | 3 months | Peripheral blood (6 mL) was obtained from healthy donors and patients before treatment and 90 days after treatment for the detection of PD-1 |
Countries
China
Outcome results
None listed