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This is a study of the clinical efficacy and mechanism study of tumor treatment vaccine (TTV, also known as Neo-BCV) in patients with recurrent and refractory advanced solid tumors.
The study aims to explore the safety and effectiveness of Neo-BCV in the treatment of advanced solid tumors.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 |
|---|---|---|---|
| Tumor treatment vaccine for patients with advanced solid tumors | Experimental | Tumor treatment vaccine(TTV) would be given deep subcutaneously in the arm or near the tumor.The check indexes are image examination (CT, MRI or PET scan) and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tumor treatment vaccine injection | Biological | Patients will receive tumor treatment vaccine(TTV), which would be given deep subcutaneously in the arm or near the tumor.The initial dose is 1ml / week, if the reaction isn't obvious, the dose can be appropriately increased to 2.5-4.0ml / week.The interval between injections can be shortened or extended depending on the patient's condition and response.The duration of treatment should be extended as long as possible, at least 6-12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Relief degree of tumors | It will be evaluated by the Response Evaluation Criteria in Solid Tumors(RECIST1.1) | The last injection |
| 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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peihua Lu, Doctor | Contact | 13621500031 | 13625653@qq.com |
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| 3 years |