PD-L1 Expression in Advanced Osteosarcoma

• Conditions: Progression; Survival
• Interventions: Other: all study participants

• 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

Arm && Interventions

Group	Intervention	Description
observation group	all study participants	All these patients who have been tested will be observed for further treatment and been recorded for toxicity.

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