Carcinoma, Esophagus Cancer
Conditions
Keywords
esophagus cancer, tumor neo-antigen DC vaccine, safety, clinical efficacy
Brief summary
The aim of this single center, single arm and prospective study is to explore the safety and efficacy of tumor antigen-sensitized DC vaccine in postoperative adjuvant treatment of esophageal cancer.
Interventions
BIOLOGICALTumor antigen-sensitized DC vaccine
subcutaneous administration
Sponsors
Sichuan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Pathologically confirmed diagnosis of esophageal squamous cell carcinoma； * Immunotherapy for preoperative； * Karnofsky performance status 0-1; * The postoperative pathological stage is (y) Pt + and / or N + M0 according to AJCC 8th * Function of the main organs is normal; * Edition Patient's written informed consent
Exclusion criteria
* Tumor emergencies; * Abnormal coagulation function; * Contagious diseases, such as HIV, HBV, HCV infection; * Mental disorders; * Concomitant tumors; * Immunological co-morbidities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0 | 3 months after the last administration of cells | Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free Survival | through study completion, an average of 1 year | Number of participants with Disease-free Survival as assessed by RECIST1.1 |
Countries
China
Outcome results
None listed