PD-L1 Expression in Advanced Osteosarcoma

• Conditions: Progression; Survival

• Registration Number: NCT03582527
• Lead Sponsor: Peking University People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2018-06-10
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-09
• Study First Posted: 2018-07-11
• Last Update Submitted: 2018-07-30
• Last Update Posted: 2018-08-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-02-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PD-L1 expression level	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 Outcome Measures

Name	Time	Method
progression free survival	2 years	from the timing of testing to disease progression/death whichever comes first
overall survival	5 years	from the timing of testing to death/last follow-up

Trial Locations

Locations (1)

Musculoskeletal Tumor Center of Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China