PD-L1 Expression in Advanced Osteosarcoma

July 30, 2018 updated by: Peking University People's Hospital

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100
        • Recruiting
        • Musculoskeletal Tumor Center of Peking University People's Hospital
        • Principal Investigator:
          • Wei Guo, M.D. and Ph.D.
        • Contact:
          • Tingting Ren, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All those advanced osteosarcoma patients who intend to receive anti-PD-1/anti-PD-L1 therapy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
observation group
All these patients who have been tested will be observed for further treatment and been recorded for toxicity.
Other: all study participants
patients will receive anti-PD-1/anti-PD-L1 antibody for further treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival
Time Frame: 2 years
from the timing of testing to disease progression/death whichever comes first
2 years
overall survival
Time Frame: 5 years
from the timing of testing to death/last follow-up
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

February 15, 2020

Study Registration Dates

First Submitted

June 10, 2018

First Submitted That Met QC Criteria

July 9, 2018

First Posted (Actual)

July 11, 2018

Study Record Updates

Last Update Posted (Actual)

August 1, 2018

Last Update Submitted That Met QC Criteria

July 30, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKUPH-sarcoma 03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Progression

Clinical Trials on all study participants

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe