SarcomaNCT06751251
The Exploration of OX40 (CD134) Expression Levels in Sarcoma Specimens and Its Clinical Application in Prognosis Determination
An observational study of Sarcoma and Biomarkers, run by Peking University People's Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Sarcoma, Biomarkers, Progression
- What is being tested?
- IHC: Immunohistochemistry and RNA-seq
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Initial treated osteosarcoma patients in PKUPH and later would recieve definitive surgery in PKUPH with complete clinical materials.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
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.
- Conditions
- Sarcoma, Biomarkers, Progression
- Being tested
- IHC: Immunohistochemistry, RNA-seq
- Keywords
- Sarcoma, OX40, Transcriptomics, Biomarker, CD134, prognosis
- Medical subject headings
- Sarcoma, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IHC: ImmunohistochemistryDiagnostic test
Immunohistochemistry will be implied in tissue sections to test the expression of OX4O in sarcoma.
RNA-seqGenetic
RNA-seq will be implied in tissue sections to test the expression of CD134 RNA expression in sarcoma.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: IHC: Immunohistochemistry; Genetic: RNA-seq | |
| 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 Receives: Diagnostic Test: IHC: Immunohistochemistry; Genetic: RNA-seq |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation of quantity of Protein OX40 Expression with clinical evaluation
Clinical evaluation according to RECIST 1.1
Measured: 6 months
Secondary outcomes (1)
correlation of quantity of CD134 RNA with event-free survival
correlation of quantity of CD134 RNA with event-free survival
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 Jan 2025
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xie Lu, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751251
- Sponsor's protocol ID
- PKUPH-sarcoma 20
- Status last verified
- Jul 2025
- First submitted
- 20 Dec 2024
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38526805Xie 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.
PubMed 29625604
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Exploration of OX40 (CD134) Expression Levels in Sarcoma Specimens and Its Clinical Application in Prognosis Determination
- ClinicalTrials.gov ID
- NCT06751251
- Acronym / sponsor ID
- PKUPH-sarcoma 20
- Conditions
- Sarcoma, Biomarkers, Progression
- Keywords
- Sarcoma, OX40, Transcriptomics, Biomarker, CD134, prognosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OX40 (CD134) expression levels of sarcoma specimens in treatment-native sarcoma patients | – | Diagnostic Test: IHC: Immunohistochemistry, Genetic: RNA-seqBefore delivering neoadjuvant chemotherapy, using IHC to test the protein expression of OX40 and using RNA-seq to test the RNA of OX40 |
| OX40 (CD134) expression levels of sarcoma specimens in chemotherapy treated sarcoma patients | – | Diagnostic Test: IHC: Immunohistochemistry, Genetic: RNA-seqAfter neoadiuyant chemotherapy, using IHC to test the protein expression of OX40 and using RNA-seq to test the RNA of OX40 |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Initial treated osteosarcoma patients in PKUPH and later would recieve definitive surgery in PKUPH with complete clinical materials.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IHC: ImmunohistochemistryImmunohistochemistry will be implied in tissue sections to test the expression of OX4O in sarcoma. | Diagnostic test | OX40 (CD134) expression levels of sarcoma specimens in chemotherapy treated sarcoma patients, OX40 (CD134) expression levels of sarcoma specimens in treatment-native sarcoma patients |
| RNA-seqRNA-seq will be implied in tissue sections to test the expression of CD134 RNA expression in sarcoma. | Genetic | OX40 (CD134) expression levels of sarcoma specimens in chemotherapy treated sarcoma patients, OX40 (CD134) expression levels of sarcoma specimens in treatment-native sarcoma patients |
Primary outcome
correlation of quantity of Protein OX40 Expression with clinical evaluation
Time frame: 6 months
Clinical evaluation according to RECIST 1.1
1 secondary outcome
correlation of quantity of CD134 RNA with event-free survival
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Background: PubMed 38526805Thapa 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.
- Background: PubMed 29625604Xie 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.
- Individual participant dataSharing planned: No
Related trials for Sarcoma
RecruitingPhase 2
A Multicenter Phase II Clinical Trial Evaluating 68Ga-HX01 Injection for PET/CT Imaging
Soft Tissue Sarcoma
RecruitingPhase 3
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
Enrolling by invitationPhase 1
Evaluation of the I-phase Clinical Trial of 177Lu-HX02 Injection in Patients With Advanced Malignant Solid Tumors
Soft Tissue Sarcoma, Non-small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma and Biomarkers, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation of quantity of Protein OX40 Expression with clinical evaluation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06751251, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.