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

NCT06665776 | Recruiting

• 1 other identifier: TCRT-HR2022
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Solid Tumor Malignancy

Keywords

NY-ESO-1; HLA-A*02:01; Solid tumor

Outcome Measures

Primary Outcomes (2)

• The frequency of HLA-A*02:01 allele in patients with confirmed diagnosed solid tumor.

  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.

  To explore the prevalence of NY-ESO-1 positive expression using immunohistochemistry (IHC) in all patients with HLA-A\*02:01 allele.

  1 day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Able to understand and voluntarily sign an informed consent form (ICF).
• Adult aged ≥ 18 years at the time of informed consent (or other age required by local regulations).
• Confirmed diagnosis of any of the following solid tumor:
• Head and neck squamous cell carcinoma, excluding nasopharyngeal carcinoma;
• Hepatocellular carcinoma;
• Lung squamous cell carcinoma;
• Synovial sarcoma;
• Triple-negative breast cancer;
• Esophageal squamous cell carcinoma;
• Cervical cancer;
• Ovarian cancer
• 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.
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.
• Body weight ≥ 50 Kg.
• Life expectancy of ≥ 6 months.

You may not qualify if:

• Known primary immunodeficiency (such as Severe Combined Immunodeficiency Disease or AIDS).
• 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.
• 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.
• Untreated or symptomatic brain metastasis.
• History of organ transplantation or allogeneic stem cell transplantation.
• Other conditions (e.g. previous use of any cell therapy) which are not suitable for enrollment at the discretion of the investigator.

Sponsors & Collaborators

• PharmaEssentia: lead

Study Sites (6)

Chang Gung Memorial Hospital, Chiayi Branch

Chiayi City, Taiwan, Taiwan

RECRUITING

Taichung Veterans General Hospital

Taichung, Taiwan, 407219, Taiwan

RECRUITING

National Cheng Kung University Hospital

Tainan, Taiwan, 704, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, Taiwan, 11217, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

RECRUITING

Taipei Medical University Hospital

Taipei, Taiwan, Taiwan

RECRUITING

Central Study Contacts

Hsi-Chi Chang

CONTACT

+886-2-2655-7688; angela_chang@pharmaessentia.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 30, 2024
• Study Start: March 14, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-06

Locations

TW (6)