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

NCT ID: NCT05633641

Last Updated: 2022-12-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-19
• Study Completion Date: 2024-12-31

Brief 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 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Xianghua Wu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cancer hospital Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

wu xiang hua, PHD

Role: CONTACT

xianghua_wu@fudan.edu.cn

18017312614

Facility Contacts

Wu X hua, doctor

Role: primary

xhwu2011@yahoo.com

13482888167

Other Identifiers

TAS-T- 20220328

Identifier Type: -

Identifier Source: org_study_id