Cancer Genome Study Using Samples From Patients Treated on Clinical Trial SHR1020-SHR-1210-II-OS

Study Overview
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Brief Summary
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RATIONALE: Studying samples of tumor tissue from patients with advanced osteosarcoma refractory to chemotherapy in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to osteosarcma treatment combining anti-angiogenesis tyrosine kinase inhibitors and anti-PD-1 antibody. PURPOSE: This research study is looking at the cancer genome using tumor samples from patients with advanced stage osteosarcoma treated on clinical trial SHR1020-SHR-1210-II-OS.

Detailed Description
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OBJECTIVES: To investigate the clinical relevance of conducting comprehensive molecular analyses on clinically annotated high-quality tumor specimens from patients with advanced stage osteosarcoma. OUTLINE: This is a single-center study. Biological specimens are collected from participating clinical site and analyzed by transcription profiling of RNA and microRNA; detection of DNA copy number changes and chromosomal rearrangements; epigenetic modifications analyses; and sequencing of genomic segments, genes, and regulatory regions to assess sequence variation. Clinical information associated with each specimen donor is also collected.

Official Title
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A Study to Assess the Therapeutic Efficacy in Advanced Osteosarcoma Patients In the Clinical Trial of SHR1020-SHR-1210-II-OS (Famitinib and Camrelizumab on Chemo-refractory Osteosarcoma) Based on Genomic Analyses of Tumor Specimens

Conditions
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Osteosarcoma

Intervention / Treatment
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* Other: cytology specimen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of high-grade osteosarcoma refractory to chemotherapy and intended to receive famitinib and camrelizumab following the protocols of SHR1020-SHR-1210-II-OS Available tumor tissue samples collected before study drug and after first progression Must have matching frozen samples of normal tissue and blood Exclusion Criteria: Patients with concurrent malignancy; patients with prior or concurrent malignancy will be allowed as long as the treating physician considers it unlikely to impact the clinical outcome of the patient Serious medical illness including but not limited to uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction or cerebrovascular event with 6 months of registration, history of chronic active hepatitis or history of human immunodeficiency virus (HIV) or an active bacterial infection will not be eligible Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| comprehensive genomic analysis group<br>Patients undergo collection of tissue samples for genomic analysis via mass spectrometry, PCR, and microarray. The therapy patients received would not be based on the results of the genomic analysis. | Other: cytology specimen<br>* Biopsy and Genetic: DNA analysis;Genetic: RNA analysis;Genetic: microarray analysis; Genetic: mutation analysis; Genetic: polymorphism analysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor mutation burden | NGS analysis, based on total exon sequencing of the specimen. Identification and characterization of tumor mutation burden. | 2 years | 
| T cell-inflamed gene expression profile (GEP) | IFN-g-related mRNA profile | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| single nucleotide variants (SNVs) | NGS analysis, based on total exon sequencing of the specimen | 2 years | 
| short insertions and deletions (indels) | NGS analysis, based on total exon sequencing of the specimen | 2 years | 
| copy-number variants (CNVs) | NGS analysis, based on total exon sequencing of the specimen | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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genomic biomarkers, famitinib, camrelizumab, tumor mutation burden, PD-L1 expression, Tcell-inflamed gene expression profile (GEP)