PD-L1 Expression in Advanced Osteosarcoma

NCT ID: NCT03582527

Last Updated: 2018-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-01

Study Completion Date

2020-02-15

Brief Summary

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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

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Conditions

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Progression Survival

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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observation group

All these patients who have been tested will be observed for further treatment and been recorded for toxicity.

all study participants

Intervention Type OTHER

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

Interventions

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all study participants

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

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Musculoskeletal Tumor Center of Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lu Xie, M.D.

Role: CONTACT

+86-13401044719

Jie Xu, M.D.

Role: CONTACT

+86-15901040835

Facility Contacts

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Tingting Ren, Ph.D.

Role: primary

Other Identifiers

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PKUPH-sarcoma 03

Identifier Type: -

Identifier Source: org_study_id

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