The PET-CT Predicting Response to Immunochemotherapy in Esophageal Cancer

Esophageal Cancer Clinical Trial

— POSITRON  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05615103
• Other study ID #: POSITRON
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

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