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The purpose of this work: to assess the tolerability and effectiveness of the autogemotherapy method on the basis of autologous antigen-activated dendritic cells in the treatment of patients with colorectal cancer.
This technology is intended for complex treatment of patients with colorectal cancer and is aimed at preventing the occurrence and treatment of secondary foci. The need for this technology is justified by the widespread occurrence of colorectal cancer, a decrease in the average age at onset of the disease, and the chemoresistantness of locally advanced forms of cancer.
Currently, technologies are being developed to improve the clinical outcomes of patients with complex treatment of colorectal cancer. Many patients are immunosuppressed after surgical, radiation and chemotherapeutic treatment, which leads to dysfunction of T cells, resulting in tumor cells avoiding immune surveillance. Restoration of antitumor immunity during immunotherapy is one of the modern approaches in the treatment of colorectal cancer, which contributes to the formation of an effective specific immune response, the destruction of tumor cells while minimizing toxicity. Dendritic cells (DC) and the lymphocytes induced by them are one of the most effective methods for the destruction of residual cancer cells, which are the leading cause of relapse and metastasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunotherapy based on dendritic cells | Experimental | Intravenous administration dendritic cell and activated mononuclear cells at least 3 times 20-30 million cells / injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunotherapy based on dendritic cells | Biological | Intravenous injection of cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Сytotoxicity | A study of the cytotoxic activity of peripheral blood mononuclear cells against tumor cells of the COLO 320 HSR line. The result will be presented as the level of cytotoxicity (%) against the cells of the tumor line. The determination of cytotoxicity is carried out using a lactate dehydrogenase test (Promega). The level of the enzyme is proportional to the level of cytotoxicity. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Parameters of peripheral blood | Leukocyte formula, the enzyme content (lactate dehydrogenase, alkaline phosphatase, liver enzymes) of C-reactive protein, creatinine | 6 months |
| Immune status indicators |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ekaterina V. Kulikova, PhD | Contact | +8(383) 222-19-10 | homchek@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sergey V. Sennikov, MD | RIFCI | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RIFCI | Recruiting | Novosibirsk | Russia |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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Patients with colorectal cancer receive a cellular preparation consisting of dendritic cells loaded with tumor lysate antigens and activated mononuclear cells.
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We investigate the content of CD 3+, CD 4+, CD 8+, CD 19+, CD 16+/56+ cells, HLA-DR on CD 14 monocytes
| 6 months |
| The content of immunosuppressive populations | We investigate the content of T-regulatory cells, myeloid suppressors, myeloid and plasmacytoid dendritic cells | 6 months |
| Interrogation of the patient using a visual analogue scale | The patient evaluates his state in points. The patient is assessed such symptoms as fatigue, irritability, anorexia, nausea, pain, sleep disturbance. | 6 months |
| Relapse-free period | A study of the period between the onset of complex treatment and immunotherapy until the recurrence of the disease. | 36 months |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |