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

Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05023928
• Other study ID #: ESOC2108
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: September 1, 2021
• Est. completion date: September 1, 2023

Study information

• Verified date: August 2021
• Source: Sichuan University
• Contact: Zhen-Yu Ding, Prof
• Email: dingzhenyu[@]scu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: September 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Esophageal Neoplasms
• Esophagus Cancer

Intervention

Biological:
• Tumor antigen-sensitized DC vaccine
subcutaneous administration

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Disease-free Survival	Number of participants with Disease-free Survival as assessed by RECIST1.1	through study completion, an average of 1 year