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

NCT05317325 | Unknown Phase 1

• 1 other identifier: HXDB-2203
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

esophageal cancer; tumour cell lysate; neoantigen; prime-boost; dendritic cell vaccine

Outcome Measures

Primary Outcomes (1)

• The number of treatment-related adverse events

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

  From the first administration of vaccine to 3 months after the last administration

Secondary Outcomes (1)

• Disease-free Survival

  from the study start to 1 year after the study completion

Study Arms (1)

Experimental Group

EXPERIMENTAL

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.

Biological: OCDC vaccine; NeoDC vaccine

Interventions

OCDC vaccine; NeoDC vaccine BIOLOGICAL

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

Experimental Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Tumor emergencies;
• Abnormal coagulation function;
• Contagious diseases, such as HIV, HBV, HCV infection;
• Mental disorders;
• Concomitant tumors;
• Immunological co-morbidities

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610000, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Zhen-Yu Ding, Prof

  Sichuan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhen-Yu Ding, Prof

CONTACT

0086288542357; dingzhenyu@scu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 7, 2022
• Study Start: April 1, 2022
• Primary Completion: December 30, 2023
• Study Completion: April 1, 2024
• Last Updated: April 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)