A Translational Study of Tumor Antigen-pulsed DC Vaccine for ESCC
Phase 1
- Conditions
- Esophageal Squamous Cell Carcinoma
- Interventions
- Biological: OCDC vaccine; NeoDC vaccine
- Registration Number
- NCT05317325
- Lead Sponsor
- Sichuan University
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental Group OCDC vaccine; NeoDC vaccine Autologous DCs pulsed with HOCl-oxidized autologous tumor lysate (OCDC) vaccine is administered in prime phase and personal neoantigen-sensitized DC(NeoDC) vaccine is administered in boost phase.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
West China Hospital
🇨🇳Chengdu, Sichuan, China