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Trial Title:
The PET-CT Predicting Response to Immunochemotherapy in Esophageal Cancer
NCT ID:
NCT05615103
Condition:
Esophageal Cancer
Conditions: Official terms:
Esophageal Neoplasms
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Eligible patients were selected according to the following criteria: pathologically
confirmed locally advanced ESCC (cT3-4anyNM0) that was potentially resectable after
neoadjuvant immunochemotherapy. All patients were treatment-naïve and had adequate
cardiopulmonary function. The exclusion criteria included previous autoimmune disease;
unable to complete planned treatment courses and no complete follow-up PET-CT scan.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
78 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Status:
Recruiting
Contact:
Last name:
Guibin Qiao, MD
Phone:
13602749153
Email:
guibinqiao@126.com
Start date:
November 8, 2022
Completion date:
December 8, 2023
Lead sponsor:
Agency:
Guangdong Provincial People's Hospital
Agency class:
Other
Collaborator:
Agency:
The First Afiiliated Hospital of Shantou University Medical College
Agency class:
Other
Collaborator:
Agency:
Shenzhen People's Hospital
Agency class:
Other
Collaborator:
Agency:
The Affiliated Cancer Hospital of Guangzhou Medical University
Agency class:
Other
Source:
Guangdong Provincial People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05615103
