Dynamic Multiomics Evaluation of Anti-HER2 and Immunotherapy in HER2 Positive Gastric Cancer

  • STATUS
    Recruiting
  • End date
    Jan 1, 2025
  • participants needed
    100
  • sponsor
    Peking University
Updated on 18 May 2022

Summary

Dynamic multiomics explore the efficacy and mechanism of anti-HER2 & immunotherapy of HER2 Positive GC

Description

The investigators will recruit 100 HER2 positive advanced gastric cancer patients.Blood and tumor tissue will be collected at treatment baseline, every time point response till disease progression. All samples will be processed by next-generation sequence , 10× genomics single-cell sequence ,whole exon sequence, proteome detection and CTC detection to explore the efficacy and mechanism of anti-HER2 & immunotherapy of HER2 positive GC.

Details
Condition HER2 Positive Advanced Gastric Cancer
Treatment ctDNA detection, CTC detection, Samples including blood and tissue collection, 10×genomics single cell RNA sequence, Whole exon sequence, Proteomics detection
Clinical Study IdentifierNCT05348161
SponsorPeking University
Last Modified on18 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Having signed informed consent
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

Previous systemic therapy for metastatic gastric cancer
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
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