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Completed

NCT Number: NCT03997747

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

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.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University People's Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cytology specimen

Other

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

Primary outcomes

  1. tumor mutation burden

    Time frame: 2 years

    NGS analysis, based on total exon sequencing of the specimen. Identification and characterization of tumor mutation burden.

  2. T cell-inflamed gene expression profile (GEP)

    Time frame: 2 years

    IFN-g-related mRNA profile

Secondary outcomes

  1. single nucleotide variants (SNVs)

    Time frame: 2 years

    NGS analysis, based on total exon sequencing of the specimen

  2. short insertions and deletions (indels)

    Time frame: 2 years

    NGS analysis, based on total exon sequencing of the specimen

  3. copy-number variants (CNVs)

    Time frame: 2 years

    NGS analysis, based on total exon sequencing of the specimen

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.
  • OrigiMed

Registry information

Official study title

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

Acronym: CSSG-02

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 25, 2019
Registry last updated
Jun 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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