Clinical trial NCT05633641: Peripheral Blood Neoantigen Specific T Cells Predict the Efficacy of Immunotherapy for Esophageal Squamous Cell Carcinoma
Official title: Clinical Study of Peripheral Blood Neoantigen Specific T Cells Predicting the Efficacy of Immunotherapy for Esophageal Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Esophageal Squamous Cell Carcinoma
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2022-12-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: locally advanced esophageal squamous cell carcinoma and advanced esophageal squamous cell carcinoma

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.


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.

Primary outcomes:
measure: ORR
timeFrame: until 1 year or recurrence
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Cancer hospital Fudan University
state: Shanghai
Study officials:
References: