Combination of Bevacizumab and Allogeneic NK Immunotherapy for Metastatic Solid Tumors

Study Overview
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Brief Summary
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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
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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).

Official Title
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Combination of Bevacizumab and Allogeneic NK Immunotherapy for Metastatic Solid Tumors

Conditions
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Malignant Solid Tumour

Intervention / Treatment
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* Drug: Bevacizumab
* Biological: NK immunotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bevacizumab and NK immunotherapy<br>In this group, the patients will receive regular Bevacizumab treatment in combination with multiple NK immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). | Drug: Bevacizumab<br>* 7.5 mg/kg, i.v, once every 3 weeks (continuous)<br>* Other names: Anti-VEGF, Avastin;Biological: NK immunotherapy<br>* Each treatment: 8 10 billion cells in all, transfusion in 3 times, i.v.<br>|
| Active Comparator: Bevacizumab<br>In this group, the patients will receive regular Bevacizumab treatment to control the tumor growth. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). | Drug: Bevacizumab<br>* 7.5 mg/kg, i.v, once every 3 weeks (continuous)<br>* Other names: Anti-VEGF, Avastin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | PFS was defined as the interval between treatment initiation and local relapse | 1 year | 
| OS | OS was calculated as the interval from treatment initiation to death. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 3 months | 
| CTC | The absolute number of CD45-CK+ CD326+ cells was used to quantitate the CTC levels. | 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 | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vascular Endothelial Growth Factor (VEGF) antibody, solid tumor, NK Immunotherapy