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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03997747

Acronym

CSSG-02

Enrollment

Registered

2019-06-25

Start date

2019-08-13

Completion date

2021-12-01

Last updated

2022-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteosarcoma

Keywords

genomic biomarkers, famitinib, camrelizumab, tumor mutation burden, PD-L1 expression, Tcell-inflamed gene expression profile (GEP)

Brief summary

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

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.

Interventions

OTHERcytology specimen

Biopsy and Genetic: DNA analysis;Genetic: RNA analysis;Genetic: microarray analysis; Genetic: mutation analysis; Genetic: polymorphism analysis

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026