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

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


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.

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


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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note