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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05615103
Other study ID # POSITRON
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 8, 2022
Est. completion date December 8, 2023

Study information

Verified date November 2022
Source Guangdong Provincial People's Hospital
Contact Guibin Qiao, MD
Phone 13602749153
Email guibinqiao@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 8, 2023
Est. primary completion date September 8, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 78 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Guangdong Provincial People's Hospital Guangzhou Guangdong

Sponsors (4)

Lead Sponsor Collaborator
Guangdong Provincial People's Hospital Shenzhen People's Hospital, The Affiliated Cancer Hospital of Guangzhou Medical University, The First Afiiliated Hospital of Shantou University Medical College

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Overall survival Overall survival rate from the date of diagnosis to the date of death, assessed up to 100 months
Secondary 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
Secondary 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
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