PD-L1 Expression in Advanced Osteosarcoma

Survival Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03582527
• Other study ID #: PKUPH-sarcoma 03
• Status: Recruiting
• Start date: June 1, 2018
• Est. completion date: February 15, 2020

Study information

• Verified date: July 2018
• Source: Peking University People's Hospital
• Contact: Lu Xie, M.D.
• Phone: +86-13401044719
• Email: sweetdoctor[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 15, 2020
• Est. primary completion date: December 31, 2019
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteosarcoma
• Progression
• Survival

Intervention

Other:
• all study participants
patients will receive anti-PD-1/anti-PD-L1 antibody for further treatment

Locations

Country	Name	City	State
China	Musculoskeletal Tumor Center of Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PD-L1 expression level	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	2 months
Secondary	progression free survival	from the timing of testing to disease progression/death whichever comes first	2 years
Secondary	overall survival	from the timing of testing to death/last follow-up	5 years