Personalized DC Vaccine for Postoperative Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Adjuvant Treatment in Cancer Patients With Neoantigen-primed DC Vaccine : a Single-arm, Open-label, Prospective Clinical Trial

Conditions
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Gastric Cancer, Hepatocellular Carcinoma, Non-Small-Cell Lung Cancer, Colon Rectal Cancer

Intervention / Treatment
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* Biological: DC vaccine subcutaneous administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with a first diagnosis of gastric cancer, hepatocellular carcinoma, non-small cell lung cancer, colorectal cancer who have undergone a curative resection or ablation Anticipated life time > 3month Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 Adequate organ functions Exclusion Criteria: Any evidence of tumor metastasis or co-existing malignant disease Tumor emergency Abnormal coagulation condition Contagious diseases, such as hepatitis B virus, hepatitis C virus, human immunodefficiency virus, tuberculosis infection Concomitant tumors Immunological co-morbidities

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cell_therapy<br>tumor neoantigen primed DC vaccines are administrated, 2-3 week interval, totally 3-5 times | Biological: DC vaccine subcutaneous administration<br>* subcutaneous administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 3 months after the last administration of cells | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cell therapy, safety, clinical efficacy, adjuvant treatment, locally advanced cancer