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Not yet recruiting NCT06776198

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

— Observational Osteosarcoma Transcriptome Tumor Microenvironment Precision Medicine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Chemotherapy.
Who it may be relevant to
Registry conditions: Osteosarcoma, Transcriptome, Tumor Microenvironment, Precision Medicine. Basic parameters: 8 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug Chemotherapy
    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 outcome measures

  • Event-free Survival (EFS) [Time frame: 2 year]
Secondary outcome measures (1)
  • Event-free Survival (EFS) for the second time [Time frame: 2 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Bagaev A, Kotlov N, Nomie K, Svekolkin V, Gafurov A, Isaeva O, Osokin N, Kozlov I, Frenkel F, Gancharova O, Almog N, Tsiper M, Ataullakhanov R, Fowler N. Conserved pan-cancer microenvironment subtypes predict response to immunotherapy. Cancer Cell. 2021 Jun 14;39(6):845-865.e7. doi: 10.1016/j.ccell.2021.04.014. Epub 2021 May 20. PMID 34019806

Identifiers

NCT: NCT06776198 · PKUPH-sarcoma 21

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗