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

Osteosarcoma Clinical Trial

— CSSG-02  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03997747
• Other study ID #: PKUPH-sarcoma 07
• Status: Completed
• Start date: August 13, 2019
• Est. completion date: December 1, 2021

Study information

• Verified date: June 2022
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteosarcoma

Intervention

Other:
• cytology specimen
Biopsy and Genetic: DNA analysis;Genetic: RNA analysis;Genetic: microarray analysis; Genetic: mutation analysis; Genetic: polymorphism analysis

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing
China	Peking University Shougang Hospital	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Peking University People's Hospital	Jiangsu HengRui Medicine Co., Ltd., OrigiMed

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tumor mutation burden	NGS analysis, based on total exon sequencing of the specimen. Identification and characterization of tumor mutation burden.	2 years
Primary	T cell-inflamed gene expression profile (GEP)	IFN-g-related mRNA profile	2 years
Secondary	single nucleotide variants (SNVs)	NGS analysis, based on total exon sequencing of the specimen	2 years
Secondary	short insertions and deletions (indels)	NGS analysis, based on total exon sequencing of the specimen	2 years
Secondary	copy-number variants (CNVs)	NGS analysis, based on total exon sequencing of the specimen	2 years