Tumor Antigen-sensitized DC Vaccine As an Adjuvant Therapy for Esophagus Cancer

NCT05023928 | Completed Phase 1

• 1 other identifier: CHANT-211
• Study Type: interventional
• Target: 25
• 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-sensitized DC vaccine in postoperative adjuvant treatment of esophageal cancer.

Conditions

Carcinoma; Esophagus Cancer

Keywords

esophagus cancer; tumor neo-antigen DC vaccine; safety; clinical efficacy

Outcome Measures

Primary Outcomes (1)

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

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

  3 months after the last administration of cells

Secondary Outcomes (1)

• Disease-free Survival

  through study completion, an average of 1 year

Study Arms (1)

Tumor antigen-sensitized DC vaccine

EXPERIMENTAL

Tumor antigen-sensitized vaccine is administrated, 1-week interval, totally 2 times. 2-week later, Neo-antigen DC vaccine is administrated, 2-week interval, totally 5 times.

Biological: Tumor antigen-sensitized DC vaccine

Interventions

Tumor antigen-sensitized DC vaccine BIOLOGICAL

subcutaneous administration

Tumor antigen-sensitized DC vaccine

Eligibility Criteria

• Age: 18 Years - 75 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；
• 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

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

Carcinoma; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; 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

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: August 21, 2021
• First Posted: August 27, 2021
• Study Start: September 1, 2021
• Primary Completion: October 1, 2023
• Study Completion: October 30, 2024
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)