Gastric CancerNCT04850716
Relationship Between Standard Treatment Efficacy and The Tumor Microenvironment in Advanced Gastric Cancer
An observational study of Gastric Cancer, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Gastric cancer is among the most common malignant tumors nationwide with high morbidity and mortality. Attributing to its insidious onset and rapid progress, 70% of patients with gastric cancer were initially diagnosed at an advanced stage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- non-intervention
- How many people
- 89 participants
- Where
- 1 siteChina
- Study dates
- 27 Apr 2021to 1 Nov 2023
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with histologically or cytologically confirmed advanced gastric cancer.
Who may be able to join
- Histologically or cytologically confirmed advanced gastric cancer.
- Willing to receive anti-tumor drug treatment.
- Willing to provide residual tumor tissues after routine clinical diagnosis for tumor microenvironment detection analysis.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
- At least one measurable lesion or non-measurable but evaluable as defined by RECIST 1.1.
Who cannot join
- 1. Human epidermal growth factor receptor 2 (HER2) is positive, that is, tissue immunohistochemical staining (IHC) (3+) or IHC (2+), and tissue fluorescence in situ hybridization (FISH) is positive.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Wangjun Liao, MD, PhD, nfyyliaowj@163.com
Wangjun Liao, MD, PhD
About this study
Official title: An Observational Study of Relationship Between Standard Treatment Efficacy and The Tumor Microenvironment in Advanced Gastric Cancer
Gastric cancer is among the most common malignant tumors nationwide with high morbidity and mortality. Attributing to its insidious onset and rapid progress, 70% of patients with gastric cancer were initially diagnosed at an advanced stage. In advanced gastric cancer, systemic treatment based on chemotherapy drugs, targeted drugs, and immune checkpoint inhibitors remains the main regimens. Among current standard treatment regimens, though HER2-positive and MSI-H/dMMR statuses indicate the treatment efficacy of trastuzumab and immune checkpoint inhibitors, there is still lack of robust biomarkers for predicting treatment efficacy. Tumor microenvironment as pivotal components of solid tumor, significantly influences therapeutic response and clinical outcome. The study is a multi-center, observational study to evaluate the relationship between standard treatment efficacy and the tumor microenvironment in advanced gastric cancer. In addition, the study comprehensively evaluated the landscape of the tumor microenvironment characteristics of gastric cancer, and aimed at establishing robust biomarkers for predicting prognosis and treatment efficacy to finetune treatment strategies.
Read the detailed description
Gastric cancer is among the most common malignant tumors nationwide with high morbidity and mortality. Attributing to its insidious onset and rapid progress, 70% of patients with gastric cancer were initially diagnosed at an advanced stage. In advanced gastric cancer, systemic treatment based on chemotherapy drugs, targeted drugs, and immune checkpoint inhibitors remains the main regimens. Among current standard treatment regimens, though HER2-positive and MSI-H/dMMR statuses indicate the treatment efficacy of trastuzumab and immune checkpoint inhibitors, there is still lack of robust biomarkers for predicting treatment efficacy. Tumor microenvironment as pivotal components of solid tumor, significantly influences therapeutic response and clinical outcome. The study is a multi-center, observational study to evaluate the relationship between standard treatment efficacy and the tumor microenvironment in advanced gastric cancer. In addition, the study comprehensively evaluated the landscape of the tumor microenvironment characteristics of gastric cancer, and aimed at establishing robust biomarkers for predicting prognosis and treatment efficacy to finetune treatment strategies. Eligible subjects were selected according to the inclusion criteria and exclusion criteria. After successful screening, the patients were treated following the clinical guidelines and the actual conditions. The residual tissue samples of the primary tumor or metastatic foci were collected to conduct the tumor microenvironment detection analysis.
- Conditions
- Gastric Cancer
- Being tested
- non-intervention
- Keywords
- Gastric Cancer, Tumor Microenvironment
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-interventionOther
non-intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Defined as the time from initiation date of first cycle to the first documentation of disease progression by independent review or to death due to any cause, whichever comes first.
Measured: 4 years
Secondary outcomes (4)
Objective Response Rate (ORR)
Defined as the percentage of patients who had a best response of complete response (CR), or partial response (PR).
Measured: 4 years
Overall Survival (OS)
Defined as the time from initiation date of first cycle until the date of first documented date of death from any cause.
Measured: 4 years
Duration Of Response (DOR)
Defined as the time from first documented response to first documented tumor progression or death from any cause.
Measured: 4 years
Disease Control Rate (DCR)
Defined as the percentage of patients who had a best response of complete response (CR), partial response (PR), or stable disease (SD).
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start27 Apr 2021
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850716
- Sponsor's protocol ID
- NFEC-2019-264
- Status last verified
- Mar 2023
- First submitted
- 18 Apr 2021
- Last updated
- 28 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shi M, Zeng D, Luo H, Xiao J, Li Y, Yuan X, Huang N, Wu J, Zheng S, Wu J, Li S, Rong X, Wang C, Jiang L, Mao Q, Qiu W, Guo J, Deng Q, Sun H, Lu X, Yu Y, Lai Y, Fang Y, Zhou R, Wang L, Huang X, Kong Y, Li J, Liang L, Bin J, Liao Y, Liao W. Tumor microenvironment RNA test to predict immunotherapy outcomes in advanced gastric cancer: The TIMES001 trial. Med. 2024 Nov 8;5(11):1378-1392.e3. doi: 10.1016/j.medj.2024.07.006. Epub 2024 Jul 31.
PubMed 39089261
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Relationship Between Standard Treatment Efficacy and The Tumor Microenvironment in Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT04850716
- Acronym / sponsor ID
- NFEC-2019-264
- Conditions
- Gastric Cancer
- Keywords
- Gastric Cancer, Tumor Microenvironment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 89 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 20 Apr 2021 (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.
Gastric cancer is among the most common malignant tumors nationwide with high morbidity and mortality. Attributing to its insidious onset and rapid progress, 70% of patients with gastric cancer were initially diagnosed at an advanced stage. In advanced gastric cancer, systemic treatment based on chemotherapy drugs, targeted drugs, and immune checkpoint inhibitors remains the main regimens. Among current standard treatment regimens, though HER2-positive and MSI-H/dMMR statuses indicate the treatment efficacy of trastuzumab and immune checkpoint inhibitors, there is still lack of robust biomarkers for predicting treatment efficacy. Tumor microenvironment as pivotal components of solid tumor, significantly influences therapeutic response and clinical outcome. The study is a multi-center, observational study to evaluate the relationship between standard treatment efficacy and the tumor microenvironment in advanced gastric cancer. In addition, the study comprehensively evaluated the landscape of the tumor microenvironment characteristics of gastric cancer, and aimed at establishing robust biomarkers for predicting prognosis and treatment efficacy to finetune treatment strategies.
Detailed description
Gastric cancer is among the most common malignant tumors nationwide with high morbidity and mortality. Attributing to its insidious onset and rapid progress, 70% of patients with gastric cancer were initially diagnosed at an advanced stage. In advanced gastric cancer, systemic treatment based on chemotherapy drugs, targeted drugs, and immune checkpoint inhibitors remains the main regimens. Among current standard treatment regimens, though HER2-positive and MSI-H/dMMR statuses indicate the treatment efficacy of trastuzumab and immune checkpoint inhibitors, there is still lack of robust biomarkers for predicting treatment efficacy. Tumor microenvironment as pivotal components of solid tumor, significantly influences therapeutic response and clinical outcome. The study is a multi-center, observational study to evaluate the relationship between standard treatment efficacy and the tumor microenvironment in advanced gastric cancer. In addition, the study comprehensively evaluated the landscape of the tumor microenvironment characteristics of gastric cancer, and aimed at establishing robust biomarkers for predicting prognosis and treatment efficacy to finetune treatment strategies. Eligible subjects were selected according to the inclusion criteria and exclusion criteria. After successful screening, the patients were treated following the clinical guidelines and the actual conditions. The residual tissue samples of the primary tumor or metastatic foci were collected to conduct the tumor microenvironment detection analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically or cytologically confirmed advanced gastric cancer.
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed advanced gastric cancer.
- Willing to receive anti-tumor drug treatment.
- Willing to provide residual tumor tissues after routine clinical diagnosis for tumor microenvironment detection analysis.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
- At least one measurable lesion or non-measurable but evaluable as defined by RECIST 1.1.
Key exclusion criteria (1 listed)
- 1. Human epidermal growth factor receptor 2 (HER2) is positive, that is, tissue immunohistochemical staining (IHC) (3+) or IHC (2+), and tissue fluorescence in situ hybridization (FISH) is positive.
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 |
|---|---|---|
| non-interventionnon-intervention | Other | – |
Primary outcome
Progression-Free Survival (PFS)
Time frame: 4 years
Defined as the time from initiation date of first cycle to the first documentation of disease progression by independent review or to death due to any cause, whichever comes first.
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: 4 years
Overall Survival (OS)
Time frame: 4 years
Duration Of Response (DOR)
Time frame: 4 years
Disease Control Rate (DCR)
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Derived from this study: PubMed 39089261Shi M, Zeng D, Luo H, Xiao J, Li Y, Yuan X, Huang N, Wu J, Zheng S, Wu J, Li S, Rong X, Wang C, Jiang L, Mao Q, Qiu W, Guo J, Deng Q, Sun H, Lu X, Yu Y, Lai Y, Fang Y, Zhou R, Wang L, Huang X, Kong Y, Li J, Liang L, Bin J, Liao Y, Liao W. Tumor microenvironment RNA test to predict immunotherapy outcomes in advanced gastric cancer: The TIMES001 trial. Med. 2024 Nov 8;5(11):1378-1392.e3. doi: 10.1016/j.medj.2024.07.006. Epub 2024 Jul 31.
- Individual participant dataSharing planned: No
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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?
An observational study of Gastric Cancer, run by Nanfang Hospital, Southern Medical 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 5 inclusion and 1 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 28 Mar 2023. 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 Wangjun Liao, MD, PhD (86-20-62787731, nfyyliaowj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04850716, which also lists 1 linked publication.
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 28 Mar 2023.