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| Name | Class |
|---|---|
| Shengxin Biotechnology Institute, Beijing | OTHER |
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The aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable breast cancer.
By enrolling patients with unresectable breast cancer adapted to enrolled criteria, this study will document for the first time the synergistic effect of cancer ablation and life information rehabilitation therapy. 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 |
|---|---|---|---|
| Cancer ablation | Active Comparator | In this group, the patients will receive ablation therapy (e.g. cryosurgery or irreversible electroporation) first for big tumors (> 2 cm). The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). |
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| Life information rehabilitation therapy | Active Comparator | In this group, the patients will drink "Qilisheng" Immunoregulatory Oral Solution for consecutive 3 months. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). |
|
| Combination therapy | Experimental | In this group, the patients will receive combination therapy, including ablation and life information rehabilitation therapy. They will receive ablation therapy (e.g. cryosurgery or irreversible electroporation) first for big tumors (> 2 cm), then drink "Qilisheng" Immunoregulatory Oral Solution for consecutive 3 months. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). |
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| Control | No Intervention | In this group, the patients will receive no special treatment and as a control group. 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 |
|---|---|---|---|---|
| Cancer ablation | Device | Tumors bigger than 2 cm are fit for ablation therapy, percutaneously under CT scan or ultrasound. |
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| Measure | Description | Time Frame |
|---|---|---|
| Relief degree of tumors | It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST） | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progress free survival（PFS） | The duration between treatment and cancer recurrence | 1 year |
| Overall survival（OS） | The duration between treatment and patient pass away |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuda cancer institute of Fuda cancer hospital | Guangzhou | Guangdong | 510665 | China |
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| ID | Term |
|---|---|
| D003452 | Cryosurgery |
| D018274 | Electroporation |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
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| Life information rehabilitation therapy | Drug | Each treatment: one bottle solution each day, consecutive 3 months, oral administration |
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| 3 years |
| D008919 | Investigative Techniques |
| D055664 | Electrochemical Techniques |