A Study of the Tumor Microenvironment Affecting the Efficacy of Immunotherapy for Esophageal Cancer
- Conditions
- Esophageal Cancer
- Interventions
- Other: no intervention
- Registration Number
- NCT06219031
- Lead Sponsor
- Renmin Hospital of Wuhan University
- Brief Summary
This study is a retrospective study of clinical specimens. The study subjects were patients with esophageal cancer who received immunotherapy. Tumor tissue specimens surgically removed from patients before treatment will be collected primarily. In situ immunohistochemistry and multicolor immunofluorescence will be performed. We hypothesize that there are differences in lipid metabolism-related proteins in tumor tissues and immune cells in the preexisting tumor microenvironment in patients with esophageal cancer prior to immunotherapy, and that there is a link between such differences and the efficacy of immunotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- Esophageal cancer patients receiving immunotherapy
- Radical esophagectomy for esophageal cancer at our institution prior to receiving immunotherapy
- Age greater than or equal to 18 years and less than or equal to 75 years old Imaging to assess patient efficacy after cycle 2 immunotherapy (CR/PR, SD/PD according to recist 1.1)
- Pathology Tumor tissue available
- Clinical and pathologic information not available
- Combined history of other malignant tumors
- Unavailability of surgically resected tissue
- Preoperative neoadjuvant therapy
- Radical esophagectomy for esophageal cancer not performed prior to immunotherapy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description valid group（CR/PR） no intervention CR/PR invalid group（SD/PD） no intervention SD/PD
- Primary Outcome Measures
Name Time Method Immunotherapy efficacy 2018-2022 Imaging to assess patient efficacy after cycle 2 immunotherapy (CR/PR, SD/PD according to Recist 1.1)
CR、PR、SD、PD 2018-2022 CR：All target lesions disappear and the short diameter of all pathologic lymph nodes (both target and non-target nodes) must be reduced to \<10 mm.
PR：At least 30% reduction in the sum of target lesion diameters from baseline levels SD：A relative increase in diameter sum of at least 20% (or the baseline value if the baseline measurement is minimal), referenced to the minimum of the sum of the diameters of all measured target lesions throughout the course of the experimental study; in addition to this, an increase in the absolute value of diameter sum of at least 5 mm must be met (the presence of one or more new lesions is also considered to be disease progression).
Translated with www.DeepL.com/Translator (free version) PD：The target lesion did not decrease to the level of PR, nor did it increase to the level of PD, and in between, the minimum value of the sum of the diameters can be used as a reference for the study.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Renmin hosptial of Wuhan University
🇨🇳Wuhan, Hubei, China