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| Name | Class |
|---|---|
| Shenzhen Hank Bioengineering Institute | OTHER |
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab and NK immunotherapy | Experimental | 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). |
|
| Bevacizumab | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | 7.5 mg/kg, i.v, once every 3 weeks (continuous) |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jibing Chen, MD, PhD | Fuda Cancer Hospital, Guangzhou | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuda cancer institute of Fuda cancer hospital | Guangzhou | Guangdong | 510665 | China |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| NK immunotherapy | Biological | Each treatment: 8~10 billion cells in all, transfusion in 3 times, i.v. |
|
| 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 |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |