Solid Tumor MalignancyNCT06665776
HLA-A*02:01 Allele Frequency and the NY-ESO-1 Expression Status in Cancer Patients in Taiwan
An observational study of Solid Tumor Malignancy, run by PharmaEssentia at 6 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Malignancy
- How many people
- 485 participants
- Where
- 6 sitesTaiwan
- Study dates
- 14 Mar 2023to 27 May 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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;
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- 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.
- Patient who agrees to provide the tumor sample for NY-ESO-1 IHC staining, from either fresh or archival tissue
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Taiwan6 sites
Chang Gung Memorial Hospital, Chiayi Branch
Chiayi City, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan, 407219
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
National Taiwan University Hospital
Taipei, Taiwan
Taipei Medical University Hospital
Taipei, Taiwan
About this study
Official title: 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.
Read the 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.
- Conditions
- Solid Tumor Malignancy
- Keywords
- NY-ESO-1, HLA-A*02:01, Solid tumor
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start14 Mar 2023
- Primary completion27 May 2026
- Study completion27 May 2026
Why it stopped: Because the Phase I trial will not go forward, patient recruitment for the pre-screening study has been terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor MalignancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 485 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- PharmaEssentia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665776
- Sponsor's protocol ID
- TCRT-HR2022
- Status last verified
- Jul 2026
- First submitted
- 28 Oct 2024
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06665776
- Acronym / sponsor ID
- TCRT-HR2022
- Conditions
- Solid Tumor Malignancy
- Keywords
- NY-ESO-1, HLA-A*02:01, Solid tumor
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Because the Phase I trial will not go forward, patient recruitment for the pre-screening study has been terminated.
- Enrolment
- 485 participants (actual)
- Lead sponsor
- PharmaEssentiaIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 27 May 2026 (actual)
- Study completion
- 27 May 2026 (actual)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (16 listed)
- 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:
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
The study was stopped early (reason given: Because the Phase I trial will not go forward, patient recruitment for the pre-screening study has been terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor Malignancy, run by PharmaEssentia at 6 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Because the Phase I trial will not go forward, patient recruitment for the pre-screening study has been terminated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of HLA-A*02:01 allele in patients with confirmed diagnosed solid tumor. (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.