A Translational Study of Tumor Antigen-pulsed DC Vaccine for ESCC

Sichuan University20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

OCDC vaccine; NeoDC vaccineBIOLOGICAL

OCDC vaccine and NeoDC vaccine are administered in a prime-boost regimen by subcutaneous injection.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

West China Hospital

Chengdu, Sichuan, China

Outcomes

Primary Outcomes

The number of treatment-related adverse events

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time frame: From the first administration of vaccine to 3 months after the last administration

Secondary Outcomes

Disease-free Survival

Number of participants with Disease-free Survival as assessed by RECIST1.1

Time frame: from the study start to 1 year after the study completion

Central Contacts

Zhen-Yu Ding, Prof

CONTACT

0086288542357 dingzhenyu@scu.edu.cn

Data from ClinicalTrials.gov

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