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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Sarcoma Biomarkers Disease Attributes Disease Progression Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Pathologic Processes Pathological Conditions, Signs and Symptoms Progression

Age range

8 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IHC: Immunohistochemistry

Diagnostic Test

Immunohistochemistry will be implied in tissue sections to test the expression of OX4O in sarcoma.

RNA-seq

Genetic

RNA-seq will be implied in tissue sections to test the expression of CD134 RNA expression in sarcoma.

Primary outcomes

correlation of quantity of Protein OX40 Expression with clinical evaluation

Time frame: 6 months

Clinical evaluation according to RECIST 1.1

Secondary outcomes

correlation of quantity of CD134 RNA with event-free survival

Time frame: 6 months

correlation of quantity of CD134 RNA with event-free survival

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Dec 27, 2024
Registry last updated: Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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