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| Name | Class |
|---|---|
| Cttq | INDUSTRY |
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Study Arms: Patients receive autologous dendritic cells pulsed with antigen peptides ID on days 15, 29, 43,57,71,99,127and 155, and nivolumab IV over 60 minutes on days 15, 29, 43,57,71,85 99 and 113.
Immune checkpoint inhibitors are increasingly drawing much attention in the therapeutic development for cancer treatment. However, many cancer patients do not respond to treatments with immune checkpoint inhibitors, partly because of the lack of tumor-infiltrating effector T cells. DC vaccine may prime patients for treatments with immune checkpoint inhibitors by inducing effector T-cell infiltration into the tumors and immune checkpoint signals. The combination of DC vaccine and an immune checkpoint inhibitor may function synergistically to induce more effective antitumor immune responses, and clinical trials to test the combination are currently needed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous dendritic cells pulsed with antigen | Experimental | peptide(WT1-H/K-HELP, Survivin-H/K-HELP,MAGE-A4-H ⁄ K-HELP and MUC1-22) . Each dose contains of 10 million activated autologous DCs. Route of Administration: Intradermal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous dendritic cells pulsed with antigen | Drug | peptide(WT1-H/K-HELP, Survivin-H/K-HELP,MAGE-A4-H ⁄ K-HELP and MUC1-22) . Each dose contains of 10 million activated autologous DCs. Route of Administration: Intradermal |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | From date of randomization until the date of first documented progression or date of death from any cause | up to 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | From date of randomization until the date of death from any cause | up to 1 year |
| Disease Control Rate (DCR) | Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zibing Wang | Contact | 18937621301 | bingziwang@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Zibing Wang | Henan Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450008 | China |
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| up to 1 year |
| Overall survival(OS) | From date of randomization until the date of death from any cause | up to 2 year |
| ID | Term |
|---|---|
| D000941 | Antigens |
| ID | Term |
|---|---|
| D001685 | Biological Factors |
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