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| Name | Class |
|---|---|
| Hangzhou Neoantigen Therapeutics Co., Ltd. | INDUSTRY |
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This research study is evaluating a new type of esophagus cancer vaccine called "Personalized Neoantigen Cancer Vaccine" as a possible treatment for esophagus cancer patients who have completed adjuvant therapy following neoadjuvant therapy and surgical resection. The purpose of the clinical study is evaluating the safety, tolerability and partial efficacy of the personalized neoantigen cancer vaccine in the treatment of resectable esophagus cancer, so as to provide a new personalized therapeutic strategy.
It is known that cancer patients have mutations (changes in genetic material) that are specific to an individual patient and tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune responses, which may help the participant's body fight any tumor cells that could cause the cancer to come back in the future. The study will examine the safety of the vaccine when given at several different time points and will examine the participant's blood cells for signs that the vaccine induced an immune response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized neoantigen vaccines | Experimental | iNeo-Vac-P01 (peptides): 300 mcg per peptide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iNeo-Vac-P01 | Biological | iNeo-Vac-P01 (peptides): 4 x 300 mcg per peptide given on days 1, 4, 8, 15, 22, 52, and 82 for a total of 7 doses; |
|
| Measure | Description | Time Frame |
|---|---|---|
| AEs | To evaluate the number of patients with clinical or laboratory adverse events (AEs) | 1 year |
| Relapse Free Survival Rate | Proportion of patients who have had surgery for less than 1 year before their first documented relapse | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse Free Survival | The time between the patient's completion of surgery and the first recorded relapse | 3 years |
| Overall Survival | From the time of the patient's surgery to the time of death |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Zhejiang University | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| D000276 | Adjuvants, Immunologic |
| D003115 | Colony-Stimulating Factors |
| ID | Term |
|---|---|
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
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|
| GM-CSF | Biological | 4 x 40 mcg (total dose 160 mcg) given on days 1, 4, 8, 15, 22, 52, and 82 for a total of 7 doses |
|
|
| 3 years |
| EORTC QLQ-C30 (version 3) | Quality of life questionnaire. All questionnaire responses were transformed linearly to scores from 0 to 100. For functional scores and global QOL, higher scores represent better function and QOL, whereas a higher score for the symptom scales represents more severe symptom. | 3 years |
| D016207 |
| Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D007155 | Immunologic Factors |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |