HLA-A*02:01 Allele Frequency and the NY-ESO-1 Expression Status in Cancer Patients in Taiwan

July 20, 2026 updated by: PharmaEssentia

A Prospective Observational Human Subject Research to Explore the HLA-A*02:01 Allele Frequency and the NY-ESO-1 Expression Status in Cancer Patients in Taiwan

This is a prospective observational research to explore the frequency of Human leukocyte antigen A allele 02:01 (HLA*02:01) and the expression status of New York esophageal squamous cell carcinoma-1 (NY-ESO-1) in cancer patients in Taiwanese population.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

T cell receptor (TCR)-engineered T cells with high affinity to NY-ESO-1 epitope presented by HLA-A*02:01 are potential therapeutic strategy against solid tumor, which show exciting results in several clinical studies. However, the prevalence of patients expressing HLA-A*02:01 and NY-ESO-1 in Taiwanese population is still unknown. This research aims to explore the prevalence of cancer patients expressing HLA-A*02:01 and NY-ESO-1 in Taiwanese population. Eligible patients with triple-negative breast cancer, hepatocellular carcinoma, head and neck squamous cell carcinoma excluding nasopharyngeal carcinoma, Lung squamous cell cancer, synovial sarcoma, esophageal squamous cell carcinoma, cervical cancer, or ovarian cancer will be enrolled. High resolution genotyping for HLA-A*02:01 and NY-ESO-1 expression status using IHC will be assessed in all enrolled patients. The frequency of HLA-A*02:01 allele and the prevalence of NY-ESO-1 positive expression will be analysed by pooled patient population and by specific tumor type.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
485

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
    • Taiwan
      • Chiayi City, Taiwan, Taiwan
        • Chang Gung Memorial Hospital, Chiayi Branch
      • Taichung, Taiwan, Taiwan, 407219
        • Taichung Veterans General Hospital
      • Tainan, Taiwan, Taiwan, 704
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, Taiwan
        • Taipei Medical University Hospital
      • Taipei, Taiwan, Taiwan
        • National Taiwan University Hospital
      • Taipei, Taiwan, Taiwan, 11217
        • Taipei Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with confirmed diagnosis of any of the following solid tumor:

  1. Head and neck squamous cell carcinoma, excluding nasopharyngeal carcinoma;
  2. Hepatocellular carcinoma;
  3. Lung squamous cell carcinoma;
  4. Synovial sarcoma;
  5. Triple-negative breast cancer;
  6. Esophageal squamous cell carcinoma;
  7. Cervical cancer;
  8. Ovarian cancer

Description

Inclusion Criteria:

  1. Able to understand and voluntarily sign an informed consent form (ICF).
  2. Adult aged ≥ 18 years at the time of informed consent (or other age required by local regulations).

  3. Confirmed diagnosis of any of the following solid tumor:

    1. Head and neck squamous cell carcinoma, excluding nasopharyngeal carcinoma;
    2. Hepatocellular carcinoma;
    3. Lung squamous cell carcinoma;
    4. Synovial sarcoma;
    5. Triple-negative breast cancer;
    6. Esophageal squamous cell carcinoma;
    7. Cervical cancer;
    8. Ovarian cancer
  4. Patient who received standard curative or palliative therapy including but not limited to any targeted therapy based on mutation status for their cancer, or patient with advanced solid tumors for which there is no accepted therapy, standard therapies are no longer effective, or the patient refuses additional standard therapy.
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.
  6. Body weight ≥ 50 Kg.
  7. Life expectancy of ≥ 6 months.
  8. Patient who agrees to provide the tumor sample for NY-ESO-1 IHC staining, from either fresh or archival tissue

Exclusion Criteria:

  1. Known primary immunodeficiency (such as Severe Combined Immunodeficiency Disease or AIDS).
  2. Uncontrolled intercurrent illness which is not suitable for enrollment at the discretion of the investigator, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements.
  3. Currently confirmed diagnosis of at least 2 active cancers; patient who was cured of the other cancer [disease free period > 6 months] and currently has only one research targeted tumor can be enrolled.
  4. Untreated or symptomatic brain metastasis.
  5. History of organ transplantation or allogeneic stem cell transplantation.
  6. Other conditions (e.g. previous use of any cell therapy) which are not suitable for enrollment at the discretion of the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The frequency of HLA-A*02:01 allele in patients with confirmed diagnosed solid tumor.
Time Frame: 1 day
To explore the frequency of HLA-A*02:01 allele using genotyping with high resolution in all eligible patients with confirmed diagnosed solid tumor.
1 day
The prevalence of NY-ESO-1 positive expression in all tumor patients with HLA-A*02:01 allele.
Time Frame: 1 day
To explore the prevalence of NY-ESO-1 positive expression using immunohistochemistry (IHC) in all patients with HLA-A*02:01 allele.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PharmaEssentia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 14, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 27, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 27, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TCRT-HR2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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