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OpenTrials
Completed

NCT Number: NCT05023928

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

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.

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Key information

Conditions

Carcinoma Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Esophagus Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

West China Hospital

Chengdu, Sichuan, 610000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Tumor antigen-sensitized DC vaccine

Biological

subcutaneous administration

Primary outcomes

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

    Time frame: 3 months after the last administration of cells

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

Secondary outcomes

  1. Disease-free Survival

    Time frame: through study completion, an average of 1 year

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

Sponsors and collaborators

Lead sponsor

Sichuan University

Other

Registry information

Official study title

Research on the Transformation of Postoperative Adjuvant Therapy of Tumor Antigen-sensitized DC Vaccine Applied to Esophagus Cancer

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Aug 27, 2021
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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