Official 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
Brief Title
Cancer Genome Study Using Samples From Patients Treated on Clinical Trial SHR1020-SHR-1210-II-OS
Protocol ID
NCT03997747
Lead Sponsor
Peking University People's Hospital
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.
Study Period
-
Enrollment Count
38 participants
Eligibility Criteria
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
Filters
Osteosarcoma
COMPLETED
CHILD
ADULT
OLDER_ADULT