Identification of Therapeutic Targets in Metastatic Gastric Cancer

April 22, 2026 updated by: CHAN SHANNON MELISSA, Chinese University of Hong Kong

Identification of Novel Therapeutic Targets in Gastric Cancer With Lymph Node or Distant Metastasis: An Explorative Study

This is a pilot study aiming at identifying novel therapeutic molecular targets in patients with gastric cancer with lymph nodes or distant metastasis. All patients who are diagnosed with gastric cancer with metastases in the Prince of Wales Hospital will be screened for eligibility.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients admitted into PWH

Description

Inclusion Criteria:

  1. Patients age >= 18, <= 80 years old
  2. Performance status (WHO) <=2
  3. Gastric adenocarcinoma with lymph node metastasis or distant metastasis such as liver metastases, lung metastases, bone metastases, peritoneum metastases
  4. Patients with isolated ovarian metastasis could be included
  5. Patients who will be undergoing neoadjuvant chemotherapy/ target therapy/ immunotherapy or palliative chemotherapy/ target therapy/ immunotherapy
  6. Ability to give written consent before the commencement of treatment

Exclusion Criteria:

  1. Patient who will not be undergoing neoadjuvant chemotherapy/ target therapy/ immunotherapy or palliative chemotherapy/ target therapy/ immunotherapy
  2. Pregnancy or breastfeeding
  3. Patients with irreversible coagulation disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Biobank construction
Time Frame: Collect at baseline(pre-treatment) and/or during interval surgery if clinically indicated and/or after completing all systemic and surgical treatment if patient required an endoscopy or laparoscopy due to clinical need only.
Recruit patients and collect the required biological samples (i.e. tumor tissues, blood and ascites samples) for biobank construction.
Collect at baseline(pre-treatment) and/or during interval surgery if clinically indicated and/or after completing all systemic and surgical treatment if patient required an endoscopy or laparoscopy due to clinical need only.
Detection of noval therapeutic targets for treating gastric cancer cancer with metastases.
Time Frame: Collect at baseline(pre-treatment) and/or during interval surgery if clinically indicated and/or after completing all systemic and surgical treatment if patient required an endoscopy or laparoscopy due to clinical need only.
Biological samples (i.e. tissue, blood and ascites samples) collected from enrolled patients will be used in genome and transcriptome analysis using next generation sequencing, DNA mutation detection using digital PCR and mass spectrometry-based proteomic.
Collect at baseline(pre-treatment) and/or during interval surgery if clinically indicated and/or after completing all systemic and surgical treatment if patient required an endoscopy or laparoscopy due to clinical need only.
Organoid culture for drug sensitivity assay
Time Frame: Collect at baseline(pre-treatment) and/or during interval surgery if clinically indicated and/or after completing all systemic and surgical treatment if patient required an endoscopy or laparoscopy due to clinical need only.
Gastric tumor tissues are collected from enrolled patients to establish patient-derived organoids and subject to drug sensitivity assay. The choice of drugs will depend on the molecular analysis results and will be advised by oncologists.
Collect at baseline(pre-treatment) and/or during interval surgery if clinically indicated and/or after completing all systemic and surgical treatment if patient required an endoscopy or laparoscopy due to clinical need only.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical Outcome - Overall survival
Time Frame: through study completion, an average of 5 year
Patients' overall survival will also be recorded.
through study completion, an average of 5 year
Clinical Outcome - Progression-free survival
Time Frame: through study completion, an average of 5 year
Patients' progression-free survival will also be recorded.
through study completion, an average of 5 year
Clinical Outcome - Karnofsky Score
Time Frame: At baseline measurement
Karnofsky Score for measuring quality of life will be recorded
At baseline measurement
Clinical Outcome - Time point of metastasis
Time Frame: Recruitment till death or 5 year
Patients' time point of metastasis, whether it is synchronous or metachronous will be recorded
Recruitment till death or 5 year
Clinical Outcome - Number of previous chemotherapy/ target therapy/ immunotherapy
Time Frame: Measured and asked at baseline
Number of previous chemotherapy/ target therapy/ immunotherapy received by the patients will be recorded
Measured and asked at baseline
Clinical Outcome - Presence of ascites
Time Frame: Recruitment till death or 5 year
Presence of ascites on recruited patients will be recorded
Recruitment till death or 5 year
Clinical Outcome - Cancer Restaging
Time Frame: Post-treatment till death or 5 year
Stage of cancer will be recorded and determined with CT/PETCT scan
Post-treatment till death or 5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2033

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2033

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023.117

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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