Clinical trial NCT06219031: A Study of the Tumor Microenvironment Affecting the Efficacy of Immunotherapy for Esophageal Cancer
Official title: A Study of the Tumor Microenvironment Affecting the Efficacy of Immunotherapy for Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with esophageal cancer receiving immunotherapy

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.


Eligibility criteria: Inclusion Criteria:

1. Esophageal cancer patients receiving immunotherapy
2. Radical esophagectomy for esophageal cancer at our institution prior to receiving immunotherapy
3. 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)
4. Pathology Tumor tissue available

Exclusion Criteria:

1. Clinical and pathologic information not available
2. Combined history of other malignant tumors
3. Unavailability of surgically resected tissue
4. Preoperative neoadjuvant therapy
5. Radical esophagectomy for esophageal cancer not performed prior to immunotherapy

Primary outcomes:
measure: Immunotherapy efficacy
timeFrame: 2018-2022
measure: CR、PR、SD、PD
timeFrame: 2018-2022
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin hosptial of Wuhan University
state: Hubei
Study officials:
References:
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