Esophageal Squamous Cell CarcinomaNCT05633641
Peripheral Blood Neoantigen Specific T Cells Predict the Efficacy of Immunotherapy for Esophageal Squamous Cell Carcinoma
An observational study of Esophageal Squamous Cell Carcinoma, run by Fudan University at 1 site in China.
Trial summary
This is a single-center clinical and exploratory study. Peripheral blood tumor antigen-specific T lymphocytes of patients with resectable esophageal cancer treated with neoadjuvant chemotherapy combined with immunotherapy and patients with advanced or metastatic esophageal cancer treated with first-line chemotherapy… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 19 Oct 2022to 31 Dec 2024
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: locally advanced esophageal squamous cell carcinoma and advanced esophageal squamous cell carcinoma
Who may be able to join
- .Volunteer to participate in clinical studies and sign informed consent. .Aged 18-70 years, expected survival > 3 months. .Gender: Male or female. .Locally advanced esophageal squamous cell carcinoma and metastatic esophageal .squamous cell carcinoma.
- .There should be at least one measurable lesion (diameter ≥10 mm according to RECIST standards, and those that have undergone TACE or ablative treatment and met the requirements by imaging can be used as the target lesion).
- .ECOG Physical state score 0-1.
- Laboratory test results within one week before enrollment meet the following conditions:
- White blood cells (WBC) ≥ 3.0x10 ^9 /L.
- Neutrophils (ANC) ≥ 1.5x10 ^9 /L (without G-CSF support).
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- Platelets ≥100 x10^9/L.
- Hemoglobin ≥100 g/L (no blood transfusion support within 7 days).
- Prothrombin time ≤1.5x upper limit time (about 14 seconds).
- Serum creatinine <2.5 mg/dl or < 1.5 times the normal high value for that age.
- Endogenous creatinine clearance ≥50 ml/min.
- Serum total bilirubin ≤ 1.5x normal high value.
- Serum alkaline phosphatase ≤ 2.5x normal high value.
- Serum aspartate aminotransferase (AST) ≤2.5x normal high value.
- Serum glutalanine aminotransferase (ALT) ≤2.5x normal high value.
- Lactate dehydrogenase level (LDH) determination.
- Determination of serum immunoglobulin content.
- Determination of serum β2 microglobulin level.
- Serum virus (CMV, EBV, HBV, HCV) negative.
Who cannot join
- .Diseases of vital organs (e.g., cardiovascular and respiratory systems) : myocardial infarction, myocardial ischemia, history of coronary artery bypass or symptoms of coronary ischemia, obstructive or restrictive lung disease.
- .The patient has poor immune tolerance and may be less responsive to immune cell therapy or prone to toxic reactions.
- .Previous autoimmune and immune deficiency diseases. .Radiotherapy pneumonia. .Oxygen dependent individuals. .Other therapeutic studies or clinical trials were enrolled within four weeks. The experimental vaccine was administered within two months. .Systemic use of glucocorticoids, hydroxyurea or immunosuppressants (such as IL-2, IFN-α, IFN-γ, GSF, mTOR inhibitors, cyclosporine, etc.) within two weeks. Except for those who have recently or are currently using inhaled hormones.
- .Chronic or recurrent severe autoimmune disease within one year. .There is an uncontrolled active infection. .2-4 during acute or persistent graft-versus-host disease (GVHD). .Patients with severe heart disease, whose condition remained unstable after treatment, had myocardial infarction, congestive heart failure, unstable angina pectoris, pericardial effusion with obvious symptoms or unstable arrhythmia within 6 months before enrollment.
- .Coagulopathy. .HIV infection.
- Previous history of other cancers excluding:
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- Patients with basal cell carcinoma or squamous cell carcinoma with active treatment and complete wound healing.
- Cure of cervical or breast carcinoma in situ for at least three years.
- The primary malignancy was completely resected and in complete remission for 5 years or more.
- .Brain metastases with symptoms of cranial hypertension. Remarks: Patients with brain metastases who have been effectively treated are eligible for admission.
- .Persons with Intellectual Disabilities. .Suspected or confirmed history of alcohol and drug abuse.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Wu X hua, doctor, 13482888167, xhwu2011@yahoo.com
About this study
Official title: Clinical Study of Peripheral Blood Neoantigen Specific T Cells Predicting the Efficacy of Immunotherapy for Esophageal Squamous Cell Carcinoma
This is a single-center clinical and exploratory study. Peripheral blood tumor antigen-specific T lymphocytes of patients with resectable esophageal cancer treated with neoadjuvant chemotherapy combined with immunotherapy and patients with advanced or metastatic esophageal cancer treated with first-line chemotherapy were detected at different time points to predict ORR after neoadjuvant chemotherapy combined with immunotherapy for resectable esophageal cancer and pCR rate, DFS after radical resection and first-line metastasis of advanced esophageal cancer Therapy combined with immunotherapy for ORR, PFS and OS.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
objective response rate
Measured: until 1 year or recurrence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start19 Oct 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianghua Wu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633641
- Sponsor's protocol ID
- TAS-T- 20220328
- Status last verified
- Nov 2022
- First submitted
- 21 Nov 2022
- Last updated
- 2 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Peripheral Blood Neoantigen Specific T Cells Predicting the Efficacy of Immunotherapy for Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05633641
- Acronym / sponsor ID
- TAS-T- 20220328
- Conditions
- Esophageal Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 Dec 2022 (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 single-center clinical and exploratory study. Peripheral blood tumor antigen-specific T lymphocytes of patients with resectable esophageal cancer treated with neoadjuvant chemotherapy combined with immunotherapy and patients with advanced or metastatic esophageal cancer treated with first-line chemotherapy were detected at different time points to predict ORR after neoadjuvant chemotherapy combined with immunotherapy for resectable esophageal cancer and pCR rate, DFS after radical resection and first-line metastasis of advanced esophageal cancer Therapy combined with immunotherapy for ORR, PFS and OS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- locally advanced esophageal squamous cell carcinoma and advanced esophageal squamous cell carcinoma
Key inclusion criteria (19 listed)
- .Volunteer to participate in clinical studies and sign informed consent. .Aged 18-70 years, expected survival > 3 months. .Gender: Male or female. .Locally advanced esophageal squamous cell carcinoma and metastatic esophageal .squamous cell carcinoma.
- .There should be at least one measurable lesion (diameter ≥10 mm according to RECIST standards, and those that have undergone TACE or ablative treatment and met the requirements by imaging can be used as the target lesion).
- .ECOG Physical state score 0-1.
- Laboratory test results within one week before enrollment meet the following conditions:
- White blood cells (WBC) ≥ 3.0x10 ^9 /L.
Key exclusion criteria (11 listed)
- .Diseases of vital organs (e.g., cardiovascular and respiratory systems) : myocardial infarction, myocardial ischemia, history of coronary artery bypass or symptoms of coronary ischemia, obstructive or restrictive lung disease.
- .The patient has poor immune tolerance and may be less responsive to immune cell therapy or prone to toxic reactions.
- .Previous autoimmune and immune deficiency diseases. .Radiotherapy pneumonia. .Oxygen dependent individuals. .Other therapeutic studies or clinical trials were enrolled within four weeks. The experimental vaccine was administered within two months. .Systemic use of glucocorticoids, hydroxyurea or immunosuppressants (such as IL-2, IFN-α, IFN-γ, GSF, mTOR inhibitors, cyclosporine, etc.) within two weeks. Except for those who have recently or are currently using inhaled hormones.
- .Chronic or recurrent severe autoimmune disease within one year. .There is an uncontrolled active infection. .2-4 during acute or persistent graft-versus-host disease (GVHD). .Patients with severe heart disease, whose condition remained unstable after treatment, had myocardial infarction, congestive heart failure, unstable angina pectoris, pericardial effusion with obvious symptoms or unstable arrhythmia within 6 months before enrollment.
- .Coagulopathy. .HIV infection.
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
ORR
Time frame: until 1 year or recurrence
objective response rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Squamous Cell Carcinoma, run by Fudan University at 1 site in China.
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 19 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact wu xiang hua, PHD (18017312614, xianghua_wu@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: until 1 year or recurrence). 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 2 Dec 2022.