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Clinical Trials/NCT03582527
NCT03582527UnknownNot Applicable

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

Peking University People's Hospital1 site in 1 country50 target enrollmentStarted: June 1, 2018Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
50
Locations
1
Primary Endpoint
PD-L1 expression level
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

PD-L1 expression level

Time Frame: 2 months

all 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 Outcomes

  • progression free survival(2 years)
  • overall survival(5 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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