The PET-CT Predicting Response to Immunochemotherapy in Esophageal Cancer

NCT05615103 | Unknown DMC

• 1 other identifier: POSITRON
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall survival

  from the date of diagnosis to the date of death, assessed up to 100 months

• 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

• Safety as measured by number of participants with Grade 3 and 4 adverse events

  Up to 12 weeks

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• pathologically confirmed locally advanced ESCC (cT3-4anyNM0) that was potentially resectable after neoadjuvant immunochemotherapy.
• treatment-naïve and had the adequate cardiopulmonary function

You may not qualify if:

• previous autoimmune disease
• unable to complete planned treatment courses and no complete follow-up PET-CT scan

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead
• First Affiliated Hospital of Shantou University Medical College: collaborator
• Shenzhen People's Hospital: collaborator
• The Affiliated Cancer Hospital of Guangzhou Medical University: collaborator

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Guibin Qiao, MD

CONTACT

13602749153; guibinqiao@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 14, 2022
• Study Start: November 8, 2022
• Primary Completion: September 8, 2023
• Study Completion: December 8, 2023
• Last Updated: November 29, 2022

Record last verified: 2022-11

Locations

CN (1)