A Study of the Tumor Microenvironment Affecting the Efficacy of Immunotherapy for Esophageal Cancer

January 24, 2024 updated by: Yongshun Chen, Renmin Hospital of Wuhan University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Esophageal cancer (EC) is the ninth most common cancer and the sixth leading cause of cancer-related death worldwide. Although the therapeutic approach of surgery combined with neoadjuvant therapy is developing rapidly, the 5-year survival rate of EC is still unsatisfactory. And immunotherapy, as an emerging treatment for solid tumors, brings new hope to EC patients. Research on neoadjuvant immunotherapy for esophageal cancer is also in full swing.

Nowadays, there are more and more studies on tumor microenvironment. It has been confirmed that immune infiltrating cells in the tumor microenvironment occupy an important position in the occurrence, metastasis and drug resistance of solid tumors. It has been confirmed that pre-existing tumor-associated immune cells in the tumor microenvironment of EC patients prior to antitumor therapy tend to predict neoadjuvant immunotherapy, while the predictive role of the pre-existing immune microenvironment in patients undergoing neoadjuvant chemotherapy has also been demonstrated. Meanwhile, the spatial distribution of immune cells in the tumor microenvironment tends to predict the response to anti-tumor therapy as well as the prognosis of EC and non-small cell lung cancer (NSCLC) patients. In addition, a clinical study by Yin, J. et al. found differences in the changes in the immune microenvironment between EC patients who received neoadjuvant immunotherapy with different efficacy.

Lipids play an important role in the tumor microenvironment. Tumor cells have strong lipid-synthesizing activity, and at the same time, the accumulation of lipids in the tumor microecology can have variable effects on the immune cells therein. Accumulation of cholesterol can lead to depletion of CD8+ T cells, however this process is reversible. At the same time the accumulation of lipids and the rise in CD36 expression levels promote the transformation of tumor-associated macrophages (TAM) towards tumor-promoting M2-type TAM. The function and activation of suppressor T cells (Treg cells) are also associated with lipid accumulation.

Our previous study found a correlation between response to immunotherapy and plasma lipid levels in esophageal cancer patients. Therefore, we analyzed the results of this lipidome and proteome to find proteins related to lipid metabolism in plasma. Our study will look for correlations between lipid metabolism-related proteins and the tumor microenvironment both to predict the efficacy of immunotherapy in EC patients.

Translated with www.DeepL.com/Translator (free version)

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Renmin hosptial of Wuhan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with esophageal cancer receiving immunotherapy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
valid group（CR/PR）
CR/PR
Other: no intervention
no intervention
invalid group（SD/PD）
SD/PD
Other: no intervention
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunotherapy efficacy
Time Frame: 2018-2022
Imaging to assess patient efficacy after cycle 2 immunotherapy (CR/PR, SD/PD according to Recist 1.1)
2018-2022
CR、PR、SD、PD
Time Frame: 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.
2018-2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Renmin Hospital of Wuhan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

January 1, 2024

Study Registration Dates

First Submitted

January 12, 2024

First Submitted That Met QC Criteria

January 12, 2024

First Posted (Actual)

January 23, 2024

Study Record Updates

Last Update Posted (Estimated)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WDRY2024-K007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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