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Cancer Genome Study Using Samples From Patients Treated on Clinical Trial SHR1020-SHR-1210-II-OS (CSSG-02)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03997747
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : December 9, 2019
Sponsor:
Collaborators:
Jiangsu HengRui Medicine Co., Ltd.
OrigiMed Co. Ltd.
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Osteosarcoma Other: cytology specimen

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
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
Actual Study Start Date : August 13, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
comprehensive genomic analysis group
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
Biopsy and Genetic: DNA analysis;Genetic: RNA analysis;Genetic: microarray analysis; Genetic: mutation analysis; Genetic: polymorphism analysis




Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Tumor samples from patients enrolled on SHR1020-SHR-1210-II-OS before administration of study drug and the first disease progression.


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients have histologically proven metastatic or locally advanced osteosarcoma, reviewed by the Pathology Committee of Peking University People's Hospital, and are not amenable to curative-intent surgery. Previous systemic chemotherapy had failed to prevent the exacerbation of disease, including high-dose methotrexate (HD-MTX), doxorubicin (ADM), cisplatin (DDP) with/without ifosfamide (IFO). Tumors have to be measurable with computed tomography scan or magnetic resonance imaging, per RECIST, version 1.1. Patients undergo collection of tissue samples for genomic analysis via mass spectrometry, PCR, and microarray.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997747


Contacts
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Contact: Lu Xie, M.D. +8613401044719 xie.lu@hotmail.com
Contact: Jie Xu, M.D. +8615901040835 xujie_pkuph@sina.com

Locations
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China, Beijing
Peking University People's Hospital Recruiting
Beijing, Beijing, China, 100044
Contact: Wei Guo, M.D.    +86-10-66583761    bonetumor@163.com   
Contact: Xin Sun, M.D.    +86-10-66583761    xinsun1981@hotmail.com   
Principal Investigator: Wei Guo, M.D.         
Peking University Shougang Hospital Recruiting
Beijing, Beijing, China
Contact: Lu Xie, M.D.    +8613401044719    xie.lu@hotmail.com   
Contact: Jie Xu, M.D.    +8615901040835    xujie_pkuph@sina.com   
Sponsors and Collaborators
Peking University People's Hospital
Jiangsu HengRui Medicine Co., Ltd.
OrigiMed Co. Ltd.
Investigators
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Principal Investigator: Wei Guo, M.D. and Ph.D. Musculoskeletal Tumor Center of Peking University People's Hospital
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Responsible Party: Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03997747    
Other Study ID Numbers: PKUPH-sarcoma 07
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking University People's Hospital:
genomic biomarkers
famitinib
camrelizumab
tumor mutation burden
PD-L1 expression
Tcell-inflamed gene expression profile (GEP)
Additional relevant MeSH terms:
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Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma