HER2 Positive Advanced Gastric CancerNCT05348161
Dynamic Multiomics Evaluation of Anti-HER2 and Immunotherapy in HER2 Positive Gastric Cancer
A study testing Samples including blood and tissue collection, CTC detection and ctDNA detection in people with HER2 Positive Advanced Gastric Cancer, run by Peking University at 1 site in China.
Trial summary
Dynamic multiomics explore the efficacy and mechanism of anti-HER2 \& immunotherapy of HER2 Positive GC Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HER2 Positive Advanced Gastric Cancer
- What is being tested?
- Samples including blood and tissue collection, CTC detection and ctDNA detection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Shen Lin, Professor, 010-88196561, Linshenpku@163.com
Shen Lin, professor
About this study
Dynamic multiomics explore the efficacy and mechanism of anti-HER2 \& immunotherapy of HER2 Positive GC
Read the 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. 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.
- Conditions
- HER2 Positive Advanced Gastric Cancer
- Being tested
- Samples including blood and tissue collection, CTC detection, ctDNA detection, 10×genomics single cell RNA sequence, Whole exon sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Samples including blood and tissue collectionProcedure or surgery
Tissue and peripheral blood sample of 100 gastric cancer patients will be collected at the baseline and time point response of therapy.
CTC detectionProcedure or surgery
Peripheral blood collected from patients will be administrated to CTC detection.
ctDNA detectionProcedure or surgery
DNA extraction from patients' peripheral blood will be measured by 741 panel DNA sequence.
10×genomics single cell RNA sequenceProcedure or surgery
Tissue collected from patients will be digested into single cell suspension and administrated to 10×genomics single cell RNA sequence.
Whole exon sequenceProcedure or surgery
DNA will be extracted from patients' tissue and administrated to whole exon sequence.
Proteomics detectionProcedure or surgery
Peripheral blood collected from patients will be administrated to proximity extension assay .
| Study group | Role | What they receive |
|---|---|---|
| Anti-HER2 & Immunotherapy | Other | Advancd gastric cancer patients received anti-HER2 \& immunotherapy ± chemotherapy Receives: Procedure: Samples including blood and tissue collection; Procedure: CTC detection; Procedure: ctDNA detection; Procedure: 10×genomics single cell RNA sequence; Procedure: Whole exon sequence; Procedure: Proteomics detection |
| Anti-HER2 | Other | Advancd gastric cancer patients received anti-HER2 ± chemotherapy. Receives: Procedure: Samples including blood and tissue collection; Procedure: CTC detection; Procedure: ctDNA detection; Procedure: 10×genomics single cell RNA sequence; Procedure: Whole exon sequence; Procedure: Proteomics detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportions of HER2 & PD-L1 positive CTC
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.
Measured: 2 months
Incidence rate of ctDNA deletion, amplification, insertion and other types of variation evaluated by next generation sequence(NGS).
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.
Measured: 2 months
Proportions of lymphocytes, stromal cells, tumor cells in tumor tissue assessed by single cell transcriptome sequence.
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.
Measured: Treatment baseline; Up to 2 months from the initial treatment; From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Incidence rate of gene deletion, amplification, insertion and other types of variation of tumor evaluated by whole exon sequence(WES).
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.
Measured: Treatment baseline; Up to 2 months from the initial treatment; From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Tumor associated proteins expression level of tumor
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.
Measured: Treatment baseline; Up to 2 months from the initial treatment; From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start1 Jan 2019
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2 Positive Advanced Gastric CancerStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Lin, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348161
- Sponsor's protocol ID
- CGOG-HER2-1001
- Status last verified
- Dec 2021
- First submitted
- 29 Jan 2022
- Last updated
- 27 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Multiomics Evaluation of Anti-HER2 and Immunotherapy in HER2 Positive Gastric Cancer
- ClinicalTrials.gov ID
- NCT05348161
- Acronym / sponsor ID
- CGOG-HER2-1001
- Conditions
- HER2 Positive Advanced Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-HER2 & Immunotherapy | Other | Procedure: Samples including blood and tissue collection, Procedure: CTC detection, Procedure: ctDNA detection, Procedure: 10×genomics single cell RNA sequence, Procedure: Whole exon sequence, Procedure: Proteomics detectionAdvancd gastric cancer patients received anti-HER2 \& immunotherapy ± chemotherapy |
| Anti-HER2 | Other | Procedure: Samples including blood and tissue collection, Procedure: CTC detection, Procedure: ctDNA detection, Procedure: 10×genomics single cell RNA sequence, Procedure: Whole exon sequence, Procedure: Proteomics detectionAdvancd gastric cancer patients received anti-HER2 ± chemotherapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Samples including blood and tissue collectionTissue and peripheral blood sample of 100 gastric cancer patients will be collected at the baseline and time point response of therapy. | Procedure or surgery | Anti-HER2, Anti-HER2 & Immunotherapy |
| CTC detectionPeripheral blood collected from patients will be administrated to CTC detection. | Procedure or surgery | Anti-HER2, Anti-HER2 & Immunotherapy |
| ctDNA detectionDNA extraction from patients' peripheral blood will be measured by 741 panel DNA sequence. | Procedure or surgery | Anti-HER2, Anti-HER2 & Immunotherapy |
| 10×genomics single cell RNA sequenceTissue collected from patients will be digested into single cell suspension and administrated to 10×genomics single cell RNA sequence. | Procedure or surgery | Anti-HER2, Anti-HER2 & Immunotherapy |
| Whole exon sequenceDNA will be extracted from patients' tissue and administrated to whole exon sequence. | Procedure or surgery | Anti-HER2, Anti-HER2 & Immunotherapy |
| Proteomics detectionPeripheral blood collected from patients will be administrated to proximity extension assay . | Procedure or surgery | Anti-HER2, Anti-HER2 & Immunotherapy |
Primary outcome
Proportions of HER2 & PD-L1 positive CTC
Time frame: 2 months
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.
Incidence rate of ctDNA deletion, amplification, insertion and other types of variation evaluated by next generation sequence(NGS).
Time frame: 2 months
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.
Proportions of lymphocytes, stromal cells, tumor cells in tumor tissue assessed by single cell transcriptome sequence.
Time frame: Treatment baseline; Up to 2 months from the initial treatment; From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
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.
Incidence rate of gene deletion, amplification, insertion and other types of variation of tumor evaluated by whole exon sequence(WES).
Time frame: Treatment baseline; Up to 2 months from the initial treatment; From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
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.
Tumor associated proteins expression level of tumor
Time frame: Treatment baseline; Up to 2 months from the initial treatment; From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Samples including blood and tissue collection, CTC detection and ctDNA detection in people with HER2 Positive Advanced Gastric Cancer, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhang Xiaotian, MD (13810995536, zhangxiaotianmed@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportions of HER2 & PD-L1 positive CTC (time frame: 2 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022; AzTrials last refreshed its copy on 7 Nov 2026.