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PD-L1 Expression in Advanced Osteosarcoma

The Expression of Programmed Death Ligand-1 (PD-L1) on Advanced Osteosarcoma Tissue and Its Influence on Prognosis

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03582527
Enrollment
50
Registered
2018-07-11
Start date
2018-06-01
Completion date
2020-02-15
Last updated
2018-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Progression, Survival

Keywords

osteosarcoma, refractory to chemotherapy, unresectable, PD-L1, VENTANA PD-L1 (SP263)

Brief summary

The expression level of PD-L1 on tumor cells is a pivotal point which might have some influence on prognosis, especially for those who might use PD-1 or PD-L1 antibody for treatment. The aim of this study is to detect the expression of PD-1 on advaced osteosarcoma patient who might use these antibodies for treatment. All those specimen should be taken by pathologist and confirmed with high tumor cellularity.

Interventions

OTHERall study participants

patients will receive anti-PD-1/anti-PD-L1 antibody for further treatment

Sponsors

Peking University People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL

Inclusion criteria

* diagnosis confirmed histologically and reviewed centrally; * received surgery in Musculoskeletal Tumor Center of Peking University People's Hospital with appropriate sample for immunohistochemical staining; * progressing upon prior treatment (completed \>4 weeks before trial entry) consisted of standard high-grade osteosarcoma chemotherapy agents including doxorubicin, cisplatin, high-dose methotrexate, and ifosfamide; metastatic relapsed and unresectable progressive disease (PD); * having measurable lesion according to RECIST 1.1; * Eastern Cooperative Oncology Group performance status 0-1 with a life expectancy \>3 months; * intend to receive anti-PD-1/anti-PD-L1 antibody for therapy.

Exclusion criteria

* fail to be followed up regularly. * sample disqualification.

Design outcomes

Primary

MeasureTime frameDescription
PD-L1 expression level2 monthsall those specimens will be tested for expression level,Tumors with ≥50% cells showing positive membrane staining were considered to have high expression of PD-L1

Secondary

MeasureTime frameDescription
progression free survival2 yearsfrom the timing of testing to disease progression/death whichever comes first
overall survival5 yearsfrom the timing of testing to death/last follow-up

Countries

China

Contacts

Primary ContactLu Xie, M.D.
sweetdoctor@163.com+86-13401044719
Backup ContactJie Xu, M.D.
xujie_pkuph@sina.com+86-15901040835

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026