Esophageal Cancer
Conditions
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.
Interventions
None listed
Sponsors
First Affiliated Hospital of Shantou University Medical College
Shenzhen People's Hospital
The Affiliated Cancer Hospital of Guangzhou Medical University
Guangdong Provincial People's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 78 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic complete response rate (pCR) | Three to five working days after surgery | The rate of pathologic complete response rate after the combined treatment of chemotherapy and immunotherapy following surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | from the date of diagnosis to the date of death, assessed up to 100 months | Overall survival rate |
| Event-free survival | 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 | EFS |
| Safety as measured by number of participants with Grade 3 and 4 adverse events | Up to 12 weeks | Number of Grade 3 and 4 adverse events as defined by CTCAE v5.0 |
Countries
China
Contacts
Primary ContactGuibin Qiao, MD
Outcome results
None listed