Esophageal Squamous Cell Carcinoma
Conditions
Keywords
esophageal cancer, tumour cell lysate, neoantigen, prime-boost, dendritic cell vaccine
Brief summary
The aim of this single center, single arm and prospective study is to explore the safety and efficacy of tumor antigen-pulsed DC vaccine( OCDC and NeoDC) for postoperative adjuvant treatment of ESCC
Interventions
BIOLOGICALOCDC vaccine; NeoDC vaccine
OCDC vaccine and NeoDC vaccine are administered in a prime-boost regimen by subcutaneous injection.
Sponsors
Sichuan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Pathologically confirmed diagnosis of esophageal squamous cell carcinoma * no preoperative adjuvant therapy * Karnofsky performance status 0-2; * The postoperative pathological stage is pT2-4 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 |
|---|---|---|
| The number of treatment-related adverse events | From the first administration of vaccine to 3 months after the last administration | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free Survival | from the study start to 1 year after the study completion | Number of participants with Disease-free Survival as assessed by RECIST1.1 |
Countries
China
Contacts
Primary ContactZhen-Yu Ding, Prof
Outcome results
None listed