Peripheral Blood Neoantigen Specific T Cells Predict the Efficacy of Immunotherapy for Esophageal Squamous Cell Carcinoma

November 30, 2022 updated by: Xianghua Wu, Fudan University

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.

Study Overview

Status

Status

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

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.

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 (Anticipated)

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.
60

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

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Cancer hospital Fudan University

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

locally advanced esophageal squamous cell carcinoma and advanced esophageal squamous cell carcinoma

Description

Inclusion Criteria:

.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).
  • 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.

Exclusion Criteria:

.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:
  • 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.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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
ORR
Time Frame: until 1 year or recurrence
objective response rate
until 1 year or recurrence

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.
Fudan University

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.
October 19, 2022

Primary Completion (Anticipated)

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.
December 31, 2023

Study Completion (Anticipated)

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.
December 31, 2024

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).
November 21, 2022

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.
November 21, 2022

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.
December 1, 2022

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.
December 2, 2022

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.
November 30, 2022

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.
November 1, 2022

More Information

Terms related to this study

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.
  • TAS-T- 20220328

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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