Precision Therapy Based on Immune Microenvironment by Transcriptome Sequencing of Osteosarcoma, a Prospective, Multi-cohort Exploratory Clinical Study
- Sponsor
- Peking University People's Hospital
- Study ID
- NCT06776198
- Status
- Not Yet Recruiting
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Conditions
- Osteosarcoma
- Precision Medicine
- Transcriptome
- Tumor Microenvironment
Eligibility Criteria
- Sex
- ALL
- Age
- 8 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Chemotherapy — DRUGGroup 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
Study Details
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.
Key Dates
- First listed
- Jan 15, 2025
- Start date
- Mar 1, 2025
- Status verified
- Jan 2025
- Primary completion
- Mar 1, 2026
- Completion
- Jun 1, 2027
Study Design
- Enrollment
- 100 participants (estimated)
Arms
- Arm: Immune-Enriched, Fibrotic Group (IE/F)
- Arm: Immune-Enriched, Non-Fibrotic Group (IE)
- Arm: Fibrotic Group (F)
- Arm: Depleted Group (D)
Primary Outcome Measure
Event-free Survival (EFS) [ Time Frame: 2 year ]
Central Contacts
- Lu Musculoskeletal Tumor Center of PKUPH, M.D.+86-86491437
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