CClinicalTrials.gg
Status unknownNCT03582527Updated Aug 1, 2018

PD-L1 Expression in Advanced Osteosarcoma

An observational study in Progression and Survival, sponsored by Peking University People's Hospital. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2018-08-01.

Sponsored by Peking University People's Hospital · Observational

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Sex
All
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Study 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.

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Conditions studied

  • Progression
  • Survival

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Keywords

  • osteosarcoma
  • refractory to chemotherapy
  • unresectable
  • PD-L1
  • VENTANA PD-L1 (SP263)
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In context

Osteosarcoma

437 studies on the registry are indexed under Osteosarcoma; 116 are open to participants now.

This study's planned enrollment of 50 is below the median of 100 across 88 observational studies indexed under Osteosarcoma.

Browse Osteosarcoma studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • fail to be followed up regularly.
  • sample disqualification.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes

Groups and cohorts

  • observation group

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

    Other: all study participants

Interventions

  • Otherall study participants

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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 2 months

Secondary outcomes

  1. progression free survival

    from the timing of testing to disease progression/death whichever comes first

    Time frame: 2 years

  2. overall survival

    from the timing of testing to death/last follow-up

    Time frame: 5 years

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Study locations

1 of 1 sites recruiting
  • Musculoskeletal Tumor Center of Peking University People's Hospital
    Beijing, Beijing 100, China
    • Tingting Ren, Ph.D. · Contact
    • Wei Guo, M.D. and Ph.D. · Principal investigator
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03582527
Lead sponsor
Peking University People's Hospital
Responsible party
Sponsor
First posted
Jul 11, 2018
Start date
Jun 1, 2018
Primary completion
Dec 31, 2019 (estimated)
Completion
Feb 15, 2020 (estimated)
Last update
Aug 1, 2018

Study contacts

Lu Xie, M.D.
Contact
sweetdoctor@163.com
+86-13401044719
Jie Xu, M.D.
Contact
xujie_pkuph@sina.com
+86-15901040835

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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