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

NCT03997747 | Completed DMC

• 1 other identifier: PKUPH-sarcoma 07
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteosarcoma

Keywords

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

Outcome Measures

Primary Outcomes (2)

• tumor mutation burden

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

  2 years

• T cell-inflamed gene expression profile (GEP)

  IFN-g-related mRNA profile

  2 years

Secondary Outcomes (3)

• single nucleotide variants (SNVs)

  2 years

• short insertions and deletions (indels)

  2 years

• copy-number variants (CNVs)

  2 years

Study Arms (1)

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

Interventions

cytology specimen OTHER

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

comprehensive genomic analysis group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator
• OrigiMed: collaborator

Study Sites (2)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Peking University Shougang Hospital

Beijing, Beijing Municipality, China

Location

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.

MeSH Terms

Conditions

Osteosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Officials

• Wei Guo, M.D. and Ph.D.

  Musculoskeletal Tumor Center of Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: June 25, 2019
• Study Start: August 13, 2019
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: June 3, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)