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The WES and RAN-seq will be performed to identify and verify neoantigens and appropriate polypeptide sequences will be verified, manufactured and protected for vaccine production by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the polypeptide vaccine for immunotherapy of human cancer patients. In this phase I study, the safety, tolerance, and preliminary efficacy of the polypeptide vaccine immunotherapy on human cancers will firstly be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-cancer Neoantigen Polypeptide Vaccine | Experimental | Anti-cancer neoantigen polypeptide vaccine will be produced to treat advanced solid tumors. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoantigen Polypeptide Vaccine | Biological | Deliver neoantigen polypeptide vaccine into patients for anti-ancer therapy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients with Dose Limiting Toxicity | A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the vaccine, which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5. | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Patients with best response as either complete remission or partial remission. | Response rates will be estimated as the percent of patients whose best response is either complete remission or partial remission by combining the data from the patients. To compare with historical data, a 95% confidence interval will be calculated for the response rate. | Six months |
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Inclusion Criteria:
1. Patients with advanced cancer; 2. Life expectancy >12 weeks; 3. Adequate heart, lung, liver, kidney, and blood function; 4. Available high quality vaccine for human use; 5. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhenfeng Zhang, MD, PhD | Contact | 0086-020-39195965 | zhangzhf@gzhmu.edu.cn | |
| Bingjia He, MD | Contact | +862039195965 | 464677938@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhenfeng Zhang, MD, PhD | Second Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | 510260 | China |
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