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

Peking University

Status: Enrolling

Conditions: HER2 Positive Advanced Gastric Cancer

Treatments: Procedure: 10×genomics single cell RNA sequence; Procedure: ctDNA detection; Procedure: Whole exon sequence; Procedure: Proteomics detection; Procedure: CTC detection; Procedure: Samples including blood and tissue collection

Study type: Interventional

Funder types: Other

Identifiers

NCT05348161

CGOG-HER2-1001

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Anti-HER2 & Immunotherapy

Other group

Description:

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

Treatment:

Procedure: Proteomics detection

Procedure: 10×genomics single cell RNA sequence

Procedure: Samples including blood and tissue collection

Procedure: ctDNA detection

Procedure: Whole exon sequence

Procedure: CTC detection

Anti-HER2

Other group

Description:

Advancd gastric cancer patients received anti-HER2 ± chemotherapy.

Treatment:

Procedure: Proteomics detection

Procedure: 10×genomics single cell RNA sequence

Procedure: Samples including blood and tissue collection

Procedure: ctDNA detection

Procedure: Whole exon sequence

Procedure: CTC detection