The PET-CT Predicting Response to Immunochemotherapy in Esophageal Cancer

Study Overview
=================
Brief Summary
-----------------
Treatment with immune checkpoint inhibitors such as programmed death receptor 1 (PD-1 inhibitors) for advanced and metastatic esophageal squamous cell carcinoma (ESCC) significantly improves patients' overall survival compared to chemotherapy alone. Despite this milestone breakthrough, immunochemotherapy also has known limitations. Indeed, only 45-72% of patients achieved objective responses. It is urgent to find out easily-determined and convenient biomarkers to identify patients who will benefit from such treatment modality. Due to the luminal structure of the esophagus, the exact diameter of esophageal tumor cannot be precisely measured per RECIST 1.1. Moreover, the definition of the metastatic lymph node in which the short-axis lengths should be longer than 1.5 cm hinders the risk of missing the smaller metastatic lymph node foci. Thus, it is difficult to implement morphology-based criteria for evaluating the neoadjuvant immunochemotherapy response. The current study aimed to investigate the role of iPERCIST in predicting tumor response and the short-term overall survival of patients with locally advanced ESCC after neoadjuvant immunochemotherapy.

Official Title
-----------------
The Efficiency of 18F-FDG PET-CT for Predicting Advanced Oesophageal Squamous Cell Carcinoma Patients' Tumor Response to Immunochemotherapy in the Neoadjuvant Setting

Conditions
-----------------
Esophageal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pathologically confirmed locally advanced ESCC (cT3-4anyNM0) that was potentially resectable after neoadjuvant immunochemotherapy. treatment-naïve and had the adequate cardiopulmonary function Exclusion Criteria: previous autoimmune disease unable to complete planned treatment courses and no complete follow-up PET-CT scan

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 78 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathologic complete response rate (pCR) | The rate of pathologic complete response rate after the combined treatment of chemotherapy and immunotherapy following surgery | Three to five working days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival rate | from the date of diagnosis to the date of death, assessed up to 100 months | 
| Event-free survival | EFS | from the date of treatment initiation to the date of first progression (local recurrence of tumor or distant metastasis) or death from any cause, assessed up to 100 months | 
| Safety as measured by number of participants with Grade 3 and 4 adverse events | Number of Grade 3 and 4 adverse events as defined by CTCAE v5.0 | Up to 12 weeks |