The Exploration of OX40 (CD134) Expression Levels in Sarcoma Specimens and Its Clinical Application in Prognosis Determination

July 5, 2025 updated by: Xie Lu, Peking University People's Hospital

This study aims to investigate the expression of OX40 (CD134) in sarcomas and its impact on prognosis, with the goal of identifying novel biomarkers for early resistance detection and optimizing treatment strategies for sarcoma patients. Sarcomas are a highly heterogeneous group of malignant tumors, for which current treatment options are often suboptimal in certain patients, and effective biomarkers to guide therapy are lacking. As a T-cell costimulatory receptor, OX40 plays a significant role in immune regulation across various solid tumors and holds promise as a potential therapeutic target.

The researcher's team has previously identified high OX40 expression in sarcomas through database analysis and validated the therapeutic efficacy of antibody-drug conjugates targeting OX40 in in vivo experiments using sarcoma cell lines in murine models. This study will evaluate the mRNA expression levels of OX40 in tumor tissues from sarcoma patients and assess OX40 protein expression using immunohistochemical staining. By integrating these findings with clinical and pathological data, the study will explore the potential of OX40 expression levels in tumor tissues as biomarkers for predicting treatment response and prognosis in primary bone tumors. The results aim to provide scientific evidence for the clinical application of OX40-targeted therapies and to propose novel therapeutic strategies to improve survival outcomes in sarcoma patients.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

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
    • Beijing
      • Beijing, Beijing, China, 100044
        • Peking University People's Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Initial treated osteosarcoma patients in PKUPH and later would recieve definitive surgery in PKUPH with complete clinical materials.

Description

Inclusion Criteria:

  • Aged 8 years or older.
  • Diagnosed with high-grade osteosarcoma or Ewing sarcoma, confirmed through clinical evaluation or histopathological examination. For patients with localized tumors or solitary pulmonary lesions, pathological confirmation is required; for patients with multiple pulmonary metastases, pathological examination is not necessary.
  • Treatment-naïve patients who have not received standard first-line chemotherapy regimens for osteosarcoma or Ewing sarcoma.(First-line chemotherapy drugs include high-dose methotrexate, anthracyclines, cisplatin, and ifosfamide. For Ewing sarcoma, the standard first-line regimen is VDC followed by IE.)
  • All other examination indicators suggest that the patient is eligible for standardized chemotherapy and surgical treatment for bone tumors.

Exclusion Criteria:

  • Inability to undergo standardized chemotherapy and surgical treatment for bone tumors at this center.
  • Refusal to adhere to follow-up according to standardized diagnostic and treatment protocols.
  • Any condition that, in the investigator's opinion, may harm the participant or prevent them from meeting or complying with the study requirements.

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
OX40 (CD134) expression levels of sarcoma specimens in treatment-native sarcoma patients
Before delivering neoadjuvant chemotherapy, using IHC to test the protein expression of OX40 and using RNA-seq to test the RNA of OX40
Diagnostic test: IHC: Immunohistochemistry
Immunohistochemistry will be implied in tissue sections to test the expression of OX4O in sarcoma.
Genetic: RNA-seq
RNA-seq will be implied in tissue sections to test the expression of CD134 RNA expression in sarcoma.
OX40 (CD134) expression levels of sarcoma specimens in chemotherapy treated sarcoma patients
After neoadiuyant chemotherapy, using IHC to test the protein expression of OX40 and using RNA-seq to test the RNA of OX40
Diagnostic test: IHC: Immunohistochemistry
Immunohistochemistry will be implied in tissue sections to test the expression of OX4O in sarcoma.
Genetic: RNA-seq
RNA-seq will be implied in tissue sections to test the expression of CD134 RNA expression in sarcoma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation of quantity of Protein OX40 Expression with clinical evaluation
Time Frame: 6 months
Clinical evaluation according to RECIST 1.1
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation of quantity of CD134 RNA with event-free survival
Time Frame: 6 months
correlation of quantity of CD134 RNA with event-free survival
6 months

Collaborators and Investigators

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

Sponsor

Peking University People's Hospital

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)

January 1, 2025

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

December 20, 2024

First Submitted That Met QC Criteria

December 20, 2024

First Posted (Actual)

December 27, 2024

Study Record Updates

Last Update Posted (Actual)

July 10, 2025

Last Update Submitted That Met QC Criteria

July 5, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKUPH-sarcoma 20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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