NCT06219031

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed
Last Updated

January 26, 2024

Status Verified

January 1, 2024

Enrollment Period

Same day

First QC Date

January 12, 2024

Last Update Submit

January 24, 2024

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (2)

  • Immunotherapy efficacy

    Imaging to assess patient efficacy after cycle 2 immunotherapy (CR/PR, SD/PD according to Recist 1.1)

    2018-2022

  • CR、PR、SD、PD

    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

Study Arms (2)

valid group（CR/PR）

CR/PR

Other: no intervention

invalid group（SD/PD）

SD/PD

Other: no intervention

Interventions

no interventionOTHER

no intervention

invalid group（SD/PD）valid group（CR/PR）

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with esophageal cancer receiving immunotherapy

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renmin hosptial of Wuhan University

Wuhan, Hubei, 430060, China

Location

Related Publications (14)

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PMID: 33538338RESULT

  • Fang P, Zhou J, Liang Z, Yang Y, Luan S, Xiao X, Li X, Zhang H, Shang Q, Zeng X, Yuan Y. Immunotherapy resistance in esophageal cancer: Possible mechanisms and clinical implications. Front Immunol. 2022 Sep 2;13:975986. doi: 10.3389/fimmu.2022.975986. eCollection 2022.

    PMID: 36119033RESULT

  • Li Q, Liu T, Ding Z. Neoadjuvant immunotherapy for resectable esophageal cancer: A review. Front Immunol. 2022 Dec 8;13:1051841. doi: 10.3389/fimmu.2022.1051841. eCollection 2022.

    PMID: 36569908RESULT

  • Lei X, Lei Y, Li JK, Du WX, Li RG, Yang J, Li J, Li F, Tan HB. Immune cells within the tumor microenvironment: Biological functions and roles in cancer immunotherapy. Cancer Lett. 2020 Feb 1;470:126-133. doi: 10.1016/j.canlet.2019.11.009. Epub 2019 Nov 12.

    PMID: 31730903RESULT

  • Yin J, Yuan J, Li Y, Fang Y, Wang R, Jiao H, Tang H, Zhang S, Lin S, Su F, Gu J, Jiang T, Lin D, Huang Z, Du C, Wu K, Tan L, Zhou Q. Neoadjuvant adebrelimab in locally advanced resectable esophageal squamous cell carcinoma: a phase 1b trial. Nat Med. 2023 Aug;29(8):2068-2078. doi: 10.1038/s41591-023-02469-3. Epub 2023 Jul 24.

    PMID: 37488287RESULT

  • Arbore G, Albarello L, Bucci G, Punta M, Cossu A, Fanti L, Maurizio A, Di Mauro F, Bilello V, Arrigoni G, Bonfiglio S, Biancolini D, Puccetti F, Elmore U, Vago L, Cascinu S, Tonon G, Rosati R, Casorati G, Dellabona P. Preexisting Immunity Drives the Response to Neoadjuvant Chemotherapy in Esophageal Adenocarcinoma. Cancer Res. 2023 Sep 1;83(17):2873-2888. doi: 10.1158/0008-5472.CAN-23-0356.

    PMID: 37350667RESULT

  • Parra ER, Zhang J, Jiang M, Tamegnon A, Pandurengan RK, Behrens C, Solis L, Haymaker C, Heymach JV, Moran C, Lee JJ, Gibbons D, Wistuba II. Immune cellular patterns of distribution affect outcomes of patients with non-small cell lung cancer. Nat Commun. 2023 Apr 25;14(1):2364. doi: 10.1038/s41467-023-37905-y.

    PMID: 37185575RESULT

  • Koundouros N, Poulogiannis G. Reprogramming of fatty acid metabolism in cancer. Br J Cancer. 2020 Jan;122(1):4-22. doi: 10.1038/s41416-019-0650-z. Epub 2019 Dec 10.

    PMID: 31819192RESULT

  • Ma X, Bi E, Lu Y, Su P, Huang C, Liu L, Wang Q, Yang M, Kalady MF, Qian J, Zhang A, Gupte AA, Hamilton DJ, Zheng C, Yi Q. Cholesterol Induces CD8+ T Cell Exhaustion in the Tumor Microenvironment. Cell Metab. 2019 Jul 2;30(1):143-156.e5. doi: 10.1016/j.cmet.2019.04.002. Epub 2019 Apr 25.

    PMID: 31031094RESULT

  • Yang W, Bai Y, Xiong Y, Zhang J, Chen S, Zheng X, Meng X, Li L, Wang J, Xu C, Yan C, Wang L, Chang CC, Chang TY, Zhang T, Zhou P, Song BL, Liu W, Sun SC, Liu X, Li BL, Xu C. Potentiating the antitumour response of CD8(+) T cells by modulating cholesterol metabolism. Nature. 2016 Mar 31;531(7596):651-5. doi: 10.1038/nature17412. Epub 2016 Mar 16.

    PMID: 26982734RESULT

  • Su P, Wang Q, Bi E, Ma X, Liu L, Yang M, Qian J, Yi Q. Enhanced Lipid Accumulation and Metabolism Are Required for the Differentiation and Activation of Tumor-Associated Macrophages. Cancer Res. 2020 Apr 1;80(7):1438-1450. doi: 10.1158/0008-5472.CAN-19-2994. Epub 2020 Feb 3.

    PMID: 32015091RESULT

  • Lim SA, Wei J, Nguyen TM, Shi H, Su W, Palacios G, Dhungana Y, Chapman NM, Long L, Saravia J, Vogel P, Chi H. Lipid signalling enforces functional specialization of Treg cells in tumours. Nature. 2021 Mar;591(7849):306-311. doi: 10.1038/s41586-021-03235-6. Epub 2021 Feb 24.

    PMID: 33627871RESULT

  • Xu C, Sun S, Johnson T, Qi R, Zhang S, Zhang J, Yang K. The glutathione peroxidase Gpx4 prevents lipid peroxidation and ferroptosis to sustain Treg cell activation and suppression of antitumor immunity. Cell Rep. 2021 Jun 15;35(11):109235. doi: 10.1016/j.celrep.2021.109235.

    PMID: 34133924RESULT

  • Gao L, Chen Y. A metabolomic and proteomic study to elucidate the molecular mechanisms of immunotherapy resistance in patients with oesophageal squamous cell carcinoma. Biomed Rep. 2023 Apr 6;18(5):36. doi: 10.3892/br.2023.1619. eCollection 2023 May.

    PMID: 37089578RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

FFPE

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 12, 2024

First Posted

January 23, 2024

Study Start

December 1, 2023

Primary Completion

December 1, 2023

Study Completion

January 1, 2024

Last Updated

January 26, 2024

Record last verified: 2024-01

Locations

CN(1)