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Clinical Trials/NCT05317325
NCT05317325
Unknown
Phase 1

A Translational Study of Tumor Antigen-pulsed Dendritic Cell Vaccine for Esophageal Squamous Cell Carcinoma

Sichuan University1 site in 1 country20 target enrollmentApril 1, 2022
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ConditionsEsophageal Squamous Cell Carcinoma

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Esophageal Squamous Cell Carcinoma
Sponsor
Sichuan University
Enrollment
20
Locations
1
Primary Endpoint
The number of treatment-related adverse events
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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

Registry
clinicaltrials.gov
Start Date
April 1, 2022
End Date
April 1, 2024
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Sichuan University
Responsible Party
Principal Investigator
Principal Investigator

Zhen-Yu Ding

Professor

Sichuan University

Eligibility Criteria

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

Outcomes

Primary Outcomes

The number of treatment-related adverse events

Time Frame: 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 Outcomes

  • Disease-free Survival(from the study start to 1 year after the study completion)

Study Sites (1)

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