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NCT Number: NCT06776198

Precision Therapy Based on Immune Microenvironment by Transcriptome Sequencing of Osteosarcoma, a Prospective, Multi-cohort Exploratory Clinical Study

Bagaev et al. have identified four tumor microenvironment (TME) subtypes that are conserved across diverse cancers and correlated with immunotherapy response in melanoma, bladder, and gastric cancers. They provided a visual tool revealing the TME subtypes integrated with targetable genomic alterations, which provided a planetary view of each tumor that can aid in oncology clinical decision making. We aim to use this tool to prospectively analyse the biopsy specimens of osteosarcomas to identify their TME subtypes so as to deliver appropriate treatment strategy if these osteosarcomas experience disease progression afterwards. We will compare the past sequencing date stored in PKUPH bank so as to compare the event-free survival(EFS) of these patients to check the Superiority of this method later.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (i) patients who have been suspected for osteosarcoma with enough clinical or radiographic information;
  • (ii) patients who have evaluable lesions to resect or follow;
  • (iii) patients who are planned to be operate with enough flesh specimens for this study.

Exclusion criteria

  • (i) clinical information was not complete;
  • (ii) lost to follow-up.

Treatment and study plan

Chemotherapy

Drug

Group IE/F: After progression, try LRRC15 ADC + PD-1 inhibitors; Group IE: After progression, try simple anti-PD-1 inhibitors; Group F: After progression, try LRRC15 ADC; Group D: After progression, try B7-H3 ADC or other irrinotecan analogue

Primary outcomes

  1. Event-free Survival (EFS)

    Time frame: 2 year

    From biopsy to progression/last follow-up

Secondary outcomes

  1. Event-free Survival (EFS) for the second time

    Time frame: 2 year

    From first progression to the second progression/last follow-up

Other outcomes

  1. Correlation with some DNA target expression

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Lu Musculoskeletal Tumor Center of PKUPH, M.D.

CONTACT

[email protected]

+86-86491437

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Acronym: PTMTO

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 15, 2025
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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