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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-70
SponsorPeking University People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

(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.

Disqualifiers

(i) clinical information was not complete;

(ii) lost to follow-up.

Trial population

Initially treated osteosarcoma

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

100 Participants
are divided into 4 treatment groups
Group A: Immune-Enriched, Fibrotic Group (IE/F)1 intervention
Group B: Immune-Enriched, Non-Fibrotic Group (IE)1 intervention
Group C: Fibrotic Group (F)1 intervention
Group D: Depleted Group (D)1 intervention

Trial outcomes

Primary outcomes

1

Event-free Survival (EFS)

From biopsy to progression/last follow-up

Time frame
2 year

Secondary outcomes

1

Event-free Survival (EFS) for the second time

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

Time frame
2 year

Other outcomes

1

Correlation with some DNA target expression

Time frame
1 year

Locations

This trial has no locations.

Sponsors and contacts

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