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The study is aimed to the test efficacy and safety of neoantigen-primed dendritic cell (DC) cell vaccine therapy for postoperative locally advanced gastric cancer, hepatocellular carcinoma, lung cancer and colorectal cancer, and to explore the biomarkers related to efficacy and adverse event.
Postoperative patients with pathological confirmed locally advanced gastric cancer, hepatocellular carcinoma, non-small cell lung cancer and colorectal cancer with standard adjuvant treatment are enrolled. This is a prospective exploratory trial. Patients' tumor tissues are subsequent to whole exosome sequencing and possible neoantigens are identified. DC is in vitro primed with synthesized peptides. Both adverse events and responses are recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cell_therapy | Experimental | tumor neoantigen primed DC vaccines are administrated, 2-3 week interval, totally 3-5 times |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DC vaccine subcutaneous administration | Biological | subcutaneous administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Survival (DFS) | Defined as the time from the surgery to the first documented disease recurrence or death (by any cause), whichever occurs first | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Defined by the time between the date of randomization and the date of death | Up to 10 years |
| Incidence of Treatment-Related Adverse Events [Safety and Tolerability] | Defined by treatment-related adverse events as assessed by CTCAE v4.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiu Li | Contact | +86 028-85422589 | liqiu@scu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qiu Li | Recruiting | Chengdu | Sichuan | 610041 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 3 months after the last administration of cells |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D008113 | Liver Neoplasms |
| D008107 | Liver Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |