Dynamic Multiomics Evaluation of Anti-HER2 and Immunotherapy in HER2 Positive Gastric Cancer
NCT ID: NCT05348161
Last Updated: 2022-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2019-01-01
2025-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Anti-HER2 & Immunotherapy
Advancd gastric cancer patients received anti-HER2 \& immunotherapy ± chemotherapy
Samples including blood and tissue collection
Tissue and peripheral blood sample of 100 gastric cancer patients will be collected at the baseline and time point response of therapy.
CTC detection
Peripheral blood collected from patients will be administrated to CTC detection.
ctDNA detection
DNA extraction from patients' peripheral blood will be measured by 741 panel DNA sequence.
10×genomics single cell RNA sequence
Tissue collected from patients will be digested into single cell suspension and administrated to 10×genomics single cell RNA sequence.
Whole exon sequence
DNA will be extracted from patients' tissue and administrated to whole exon sequence.
Proteomics detection
Peripheral blood collected from patients will be administrated to proximity extension assay .
Anti-HER2
Advancd gastric cancer patients received anti-HER2 ± chemotherapy.
Samples including blood and tissue collection
Tissue and peripheral blood sample of 100 gastric cancer patients will be collected at the baseline and time point response of therapy.
CTC detection
Peripheral blood collected from patients will be administrated to CTC detection.
ctDNA detection
DNA extraction from patients' peripheral blood will be measured by 741 panel DNA sequence.
10×genomics single cell RNA sequence
Tissue collected from patients will be digested into single cell suspension and administrated to 10×genomics single cell RNA sequence.
Whole exon sequence
DNA will be extracted from patients' tissue and administrated to whole exon sequence.
Proteomics detection
Peripheral blood collected from patients will be administrated to proximity extension assay .
Interventions
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Samples including blood and tissue collection
Tissue and peripheral blood sample of 100 gastric cancer patients will be collected at the baseline and time point response of therapy.
CTC detection
Peripheral blood collected from patients will be administrated to CTC detection.
ctDNA detection
DNA extraction from patients' peripheral blood will be measured by 741 panel DNA sequence.
10×genomics single cell RNA sequence
Tissue collected from patients will be digested into single cell suspension and administrated to 10×genomics single cell RNA sequence.
Whole exon sequence
DNA will be extracted from patients' tissue and administrated to whole exon sequence.
Proteomics detection
Peripheral blood collected from patients will be administrated to proximity extension assay .
Eligibility Criteria
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Inclusion Criteria
* Age:18-80 years old
* HER2 overexpression confirmed by IHC or ISH (IHC 3+,or IHC2+/ISH+)
* Histologically confirmed gastric adenocarcinoma
* Unresectable recurrent or metastatic gastric cancer
* Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months
* Measurable disease according to the RECIST criteria
* Karnofsky performance status ≥70
* Life expectancy of ≥3 month
* No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
* ALT and AST\<2.5 times ULN (≤5 times ULN in patients with liver metastases)
* Serum albumin level ≥3.0g/dL
* Serum AKP \< 2.5 times ULN
* Serum creatinine \<ULN, and CCr \< 60ml/min
* Bilirubin level \< 1.5 ULN
* WBC\>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, Hb\>9g/dl
Exclusion Criteria
* Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on.
* Allergic constitution or allergic history to protium biologic product or any investigating agents.
* Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension.
* Pregnancy or lactation period
* Other previous malignancy within 5 year, except non-melanoma skin cancer
* Legal incapacity
18 Years
80 Years
ALL
No
Sponsors
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Peking University
OTHER
Responsible Party
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Shen Lin
Professor
Locations
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CGOG-HER2-1001
Identifier Type: -
Identifier Source: org_study_id
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