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| Name | Class |
|---|---|
| Jinan University Guangzhou | OTHER |
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The aim of this study is the safety and efficacy of mix vaccine to small metastases of colorectal cancer.
By enrolling patients with small metastases of colorectal cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of mix vaccine.
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 |
|---|---|---|---|
| Mix vaccine | Experimental | In this group, the patients will receive mix vaccine. The check indexes are image examination (CT, MRI or PET scan) and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). |
|
| Control | No Intervention | In this group, the patients will receive no special treatment and as a control group. The check indexes are image examination (CT, MRI or PET scan) and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mix vaccine | Biological | Each treatment: 0.5 ml /week, Subcutaneous injection of the deltoid muscle |
|
| 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 from the beginning of treatment to cancer recurrence or progression | 1 year |
| Overall survival（OS） | The duration from the beginning of treatment to patient death |
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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 |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D016233 | Immunotherapy, Active |
| ID | Term |
|---|---|
| D007114 | Immunization |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
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| 3 years |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D013812 |
| Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |