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

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

Clinical Study of Peripheral Blood Neoantigen Specific T Cells Predicting the Efficacy of Immunotherapy for Esophageal Squamous Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05633641
• Other study ID #: TAS-T- 20220328
• Status: Recruiting
• Start date: October 19, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2022
• Source: Fudan University
• Contact: wu xiang hua, PHD
• Phone: 18017312614
• Email: xianghua_wu[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 ß2 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-a, IFN-?, 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Locations

Country	Name	City	State
China	Cancer hospital Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	objective response rate	until 1 year or recurrence