Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Stomach Neoplasms

Neoplastic Cells, Circulating

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Collect peripheral blood sample of 50 gastric cancer patients pre-chemotherapy and post two cycles of chemotherapy(response evaluation).

Blood samples will be transferred to central lab to detect HER2 positive CTCs by Cellsearch epithelial kit.

Tumor response evaluation will be performed after two cycles of chemotherapy by CT/MRI based on RECIST. Clinical data, including tumor stage, metastastic organ, chemotherapy regimen, objective response, progression free survival, overall survival, etc, will be collected according to study protocol.

Cell Search® CTC epithelial kit

lin shen, MD. PhD

xiaotian zhang, MD. PhD

jifang gong, MD. PhD

Lin Shen, MD. PhD

To identify the correlation of HER2 expression in tissue and peripheral CTC. to identify the HER2 expression in CTCs with clinical prognosis in advanced/metastatic gastric cancer.

Confirm the presence of CTCs are sensitive for monitoring response to chemotherapy.

HER2 Positive CTC in Advanced Gastric Cancer

Clinical Significance of HER2 Positive Circulating Tumor Cells(CTCs) in the Peripheral Blood of Patients With Advanced Gastric Cancer

Peking University

Director of GI oncology

All Drugs and Chemicals

Immunomodulating Agents

Advancd gastric cancer patients received anti-HER2 \& immunotherapy ± chemotherapy

Advancd gastric cancer patients received anti-HER2 ± chemotherapy.

Tissue and peripheral blood sample of 100 gastric cancer patients will be collected at the baseline and time point response of therapy.

Samples including blood and tissue collection

Peripheral blood collected from patients will be administrated to CTC detection.

CTC detection

DNA extraction from patients' peripheral blood will be measured by 741 panel DNA sequence.

ctDNA detection

Tissue collected from patients will be digested into single cell suspension and administrated to 10×genomics single cell RNA sequence.

10×genomics single cell RNA sequence

DNA will be extracted from patients' tissue and administrated to whole exon sequence.

Whole exon sequence

Peripheral blood collected from patients will be administrated to proximity extension assay .

Proteomics detection

Zhang Xiaotian, MD

Shen Lin, Professor

Shen Lin, professor

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

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.

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

Numbers of CTC and proportions of HER2 or PD-L1 positive CTC collected at treatment baseline and every time point response will be calculated and recorded. Proportions of HER2 and PD-L1 positive CTC will be compared between two groups.

NGS will be proceeded to detect the ctDNA variations features at treatment baseline and every time point response will be recorded and compared between two groups.

single cell digested from tumor tissue will be administrated to 10× genomics single cell transcriptome sequence. Proportions of lymphocytes, stromal cells, tumor cells assessed by single cell transcriptome sequence at treatment baseline, the second time point response and disease progression time point will be recorded and compared between two groups.

DNA extracted from tumor tissue will be administrated to whole exon sequence.Variation features at treatment baseline, the second time point response and disease progression time point will be recorded and compared between two groups.

96 tumor associated proteins' expression level of tumor at treatment baseline, second time point response and disease progression time point will be recorded and compared between two groups.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
HER2 Positive CTC in Advanced Gastric Cancer	NCT01847794	HER2 Positive A...	Cell Search® CT...	18 Years -	Peking University
HER2 Positive CTC in Advanced Gastric Cancer	NCT01847794	HER2 Positive A...	Cell Search® CT...	18 Years -	Peking University
Dynamic Multiomics Evaluation of Anti-HER2 and Immunotherapy in HER2 Positive Gastric Cancer	NCT05348161	HER2 Positive A...	Samples includi... CTC detection ctDNA detection 10×genomics sin... Whole exon sequ... Proteomics dete...	18 Years - 80 Years	Peking University

Spots Global Cancer Trial Database for her2 positive advanced gastric cancer