Status:
UNKNOWN
Dynamic Multiomics Evaluation of Anti-HER2 and Immunotherapy in HER2 Positive Gastric Cancer
Lead Sponsor:
Peking University
Conditions:
HER2 Positive Advanced Gastric Cancer
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Dynamic multiomics explore the efficacy and mechanism of anti-HER2 \& immunotherapy of HER2 Positive GC
Detailed 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. Al...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05348161
Start Date
January 1 2019
End Date
January 1 2025
Last Update
April 27 2022
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142