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The main purpose of this study is to explore the PK/PD changes of NMN and DC cells after oral NMN combined with DC cells injection in patients after tumor surgery, and evaluate the biological age of adults, TCR diversity, SiRT1 expression level, SF-36 quality of life, OS, antigen specific immune response (TAA), cytokines and so on. In this study, 20 postoperative tumor patients who meet the entry and excretion criteria were recruited to explore the clinical potential of NMN combined with DC cell vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orally take NMN (Vital NAD) combined with DC cell vaccine injection | Experimental | The arm is a combination of two drugs. The first NMN is a precursor of NAD+, which is used orally. DC vaccine is a kind of immune cells expanded in vitro and used by injection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral NMN combined with DC cell vaccine | Drug | The whole intervention cycle was treated with NMN (Vital NAD) 600mg/day for at least 50 days. During this period, the first DC cell injection was given on the 10th day, and then another DC cell injection was given at 2 weeks, 4 weeks and 6 weeks after the first injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of double antibodies in peripheral blood | Up to 3 months | |
| Concentration of NMN (nicotinamide mononucleotide) in peripheral blood | Up to 3 months | |
| Peripheral blood NAD+ | Up to 3 months | |
| Cytokines (IL6, TNF- goat, INF- γ, IL-4, IL-10) | Up to 3 months | |
| T cell depletion index (PD1/Tim-3/lag3) | Up to 3 months | |
| T cell activation index CD107 | Up to 3 months | |
| T cell and NK cell function index (INF- γ) and granzyme | Up to 3 months | |
| High quality Survival benefit Endpoint (DFS) | DFS refers to the time from the beginning of treatment to the recurrence of the disease or the death of the patient. Patients need to be followed up regularly to keep records. | Up to 15 years |
| Survival benefit (OS) | OS refers to the time from the beginning of randomization to death (for any reason). Patients need to be followed up regularly to keep records. | Up to 15 years |
| Distant Metastasis-Free Survival (DMFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinxing Lou | Contact | +86-18911335396 | loujx@shcell.com | |
| Shuan Liu | Contact | +8617749122881 | liushuan@shcell.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mengchao Cancer Hospital | Shanghai | Shanghai Municipality | 200240 | China |
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|
Metastasis-free survival time. Patients need to be followed up regularly to keep records. |
| Up to 15 years |