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

NCT ID: NCT06751251

Last Updated: 2025-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Sarcoma Biomarkers Progression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

IHC: Immunohistochemistry

Intervention Type DIAGNOSTIC_TEST

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

RNA-seq

Intervention Type GENETIC

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

IHC: Immunohistochemistry

Intervention Type DIAGNOSTIC_TEST

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

RNA-seq

Intervention Type GENETIC

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

Interventions

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IHC: Immunohistochemistry

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

Intervention Type DIAGNOSTIC_TEST

RNA-seq

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

Intervention Type GENETIC

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xie Lu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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Thapa B, Kato S, Nishizaki D, Miyashita H, Lee S, Nesline MK, Previs RA, Conroy JM, DePietro P, Pabla S, Kurzrock R. OX40/OX40 ligand and its role in precision immune oncology. Cancer Metastasis Rev. 2024 Sep;43(3):1001-1013. doi: 10.1007/s10555-024-10184-9. Epub 2024 Mar 25.

Reference Type BACKGROUND
PMID: 38526805 (View on PubMed)

Xie L, Guo W, Wang Y, Yan T, Ji T, Xu J. Apatinib for advanced sarcoma: results from multiple institutions' off-label use in China. BMC Cancer. 2018 Apr 6;18(1):396. doi: 10.1186/s12885-018-4303-z.

Reference Type BACKGROUND
PMID: 29625604 (View on PubMed)

Other Identifiers

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PKUPH-sarcoma 20

Identifier Type: -

Identifier Source: org_study_id

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