Gastric AdenocarcinomaNCT04850729
Relationship Between Perioperative Treatment Efficacy and The Tumor Microenvironment for Locally Advanced Resectable Gastric Cancer.
An observational study of Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Perioperative drug treatment has gradually become the standard regimen for locally advanced gastric cancer, whereas only a subset of patients could benefit from it. Therefore, one major challenge for perioperative drug treatment is to construct promising biomarkers and to screen out potential beneficial patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- non-intervention
- How many people
- 169 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2021to 1 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with histologically or cytologically confirmed locally advanced resectable gastric and gastro-oesophageal junction adenocarcinoma.
Who may be able to join
- Histologically or cytologically confirmed locally advanced resectable gastric and gastro-oesophageal junction adenocarcinoma at the stage of cT2-T4aNxM0 (AJCC 8th) without distant metastases and without infiltration of adjacent structures and organs.
- 18-75 years old.
- Willing to provide residual tumor tissues after routine clinical diagnosis for tumor microenvironment detection analysis.
- Patients agree to participate in the study and sign the informed consent.
- Patients need to receive perioperative drug therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
Who cannot join
- 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.
- Patients with major cardiovascular and cerebrovascular diseases (such as congestive heart failure, unstable heart colic, atrial fibrillation, stroke, transient ischemic attack, etc.).
- Allergies or contraindications to common chemotherapy drugs, immunotherapy drugs or the ingredients.
- Women who are pregnant, breast-feeding.
- Other conditions the investigator believes that it is not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
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 Perioperative Treatment Efficacy and The Tumor Microenvironment for Locally Advanced Resectable Gastric and Gastro-oesophageal Junction Adenocarcinoma
Perioperative drug treatment has gradually become the standard regimen for locally advanced gastric cancer, whereas only a subset of patients could benefit from it. Therefore, one major challenge for perioperative drug treatment is to construct promising biomarkers and to screen out potential beneficial patients. Recent evidence has revealed that tumor microenvironment (TME) is highly associated with the prognosis of gastric cancer. Meanwhile, tumor microenvironment score (TMEscore) established with transcriptomic data is a robust biomarker for predicting prognosis and guiding individualized immunotherapy strategies. However, its predictive value for perioperative drug treatment outcomes warrants further exploration and validation. The study is a multi-center, observational study to evaluate the relationship between the efficacy of perioperative treatment and tumor microenvironment in patients with locally advanced resectable gastric and gastro-oesophageal junction adenocarcinoma, aiming at further determining the predictive value of TMEscore and establishing a comprehensive treatment-efficacy evaluation system for gastric cancer.
Read the detailed description
Perioperative drug treatment has gradually become the standard regimen for locally advanced gastric cancer, whereas only a subset of patients could benefit from it. Therefore, one major challenge for perioperative drug treatment is to construct promising biomarkers and to screen out potential beneficial patients. Recent evidence has revealed that tumor microenvironment (TME) is highly associated with the prognosis of gastric cancer. Meanwhile, tumor microenvironment score (TMEscore) established with transcriptomic data is a robust biomarker for predicting prognosis and guiding individualized immunotherapy strategies. However, its predictive value for perioperative drug treatment outcomes warrants further exploration and validation. The study is a multi-center, observational study to evaluate the relationship between the efficacy of perioperative treatment and tumor microenvironment in patients with locally advanced resectable gastric and gastro-oesophageal junction adenocarcinoma, aiming at further determining the predictive value of TMEscore and establishing a comprehensive treatment-efficacy evaluation system for gastric cancer. Eligible subjects were selected according to the inclusion criteria and exclusion criteria. After the successful screening, the patients were treated in accordance with the clinical guidelines and the actual conditions. The residual tissue samples of the primary tumor were collected to conduct the tumor microenvironment detection. After routine neoadjuvant therapy, followed by a restaging of the tumor status and surgery. The residual surgical specimens were collected to conduct the tumor microenvironment detection analysis.
- 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.
Major pathologic response (MPR) rate
Defined as <10% residual viable tumor cells in the resection specimen after neoadjuvant drug treatment.
Measured: From the initiation date of first cycle to the date of surgery, an average of 10 weeks
Secondary outcomes (3)
Pathological complete response (pCR) rate
Defined as the percentage of participants having a pathological complete response.
Measured: From the initiation date of first cycle to the date of surgery, an average of 10 weeks
R0 resection rate
Rate of microscopically margin-negative resection.
Measured: From the initiation date of first cycle to the date of surgery, an average of 10 weeks
Disease-free Survival (DFS)
Defined as the time from post-surgery baseline scan until the first occurrence of local/distant recurrence or death from any cause and is based on RECIST 1.1 as assessed by the investigator.
Measured: 3 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 start25 May 2021
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (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 AdenocarcinomaStudies 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
- 169 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
- NCT04850729
- Sponsor's protocol ID
- NFEC-2021-082
- Status last verified
- May 2025
- First submitted
- 18 Apr 2021
- Last updated
- 30 May 2025
- 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 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Relationship Between Perioperative Treatment Efficacy and The Tumor Microenvironment for Locally Advanced Resectable Gastric and Gastro-oesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT04850729
- Acronym / sponsor ID
- NFEC-2021-082
- Keywords
- Gastric Cancer, Tumor Microenvironment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 169 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 25 May 2021 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (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.
Perioperative drug treatment has gradually become the standard regimen for locally advanced gastric cancer, whereas only a subset of patients could benefit from it. Therefore, one major challenge for perioperative drug treatment is to construct promising biomarkers and to screen out potential beneficial patients. Recent evidence has revealed that tumor microenvironment (TME) is highly associated with the prognosis of gastric cancer. Meanwhile, tumor microenvironment score (TMEscore) established with transcriptomic data is a robust biomarker for predicting prognosis and guiding individualized immunotherapy strategies. However, its predictive value for perioperative drug treatment outcomes warrants further exploration and validation. The study is a multi-center, observational study to evaluate the relationship between the efficacy of perioperative treatment and tumor microenvironment in patients with locally advanced resectable gastric and gastro-oesophageal junction adenocarcinoma, aiming at further determining the predictive value of TMEscore and establishing a comprehensive treatment-efficacy evaluation system for gastric cancer.
Detailed description
Perioperative drug treatment has gradually become the standard regimen for locally advanced gastric cancer, whereas only a subset of patients could benefit from it. Therefore, one major challenge for perioperative drug treatment is to construct promising biomarkers and to screen out potential beneficial patients. Recent evidence has revealed that tumor microenvironment (TME) is highly associated with the prognosis of gastric cancer. Meanwhile, tumor microenvironment score (TMEscore) established with transcriptomic data is a robust biomarker for predicting prognosis and guiding individualized immunotherapy strategies. However, its predictive value for perioperative drug treatment outcomes warrants further exploration and validation. The study is a multi-center, observational study to evaluate the relationship between the efficacy of perioperative treatment and tumor microenvironment in patients with locally advanced resectable gastric and gastro-oesophageal junction adenocarcinoma, aiming at further determining the predictive value of TMEscore and establishing a comprehensive treatment-efficacy evaluation system for gastric cancer. Eligible subjects were selected according to the inclusion criteria and exclusion criteria. After the successful screening, the patients were treated in accordance with the clinical guidelines and the actual conditions. The residual tissue samples of the primary tumor were collected to conduct the tumor microenvironment detection. After routine neoadjuvant therapy, followed by a restaging of the tumor status and surgery. The residual surgical specimens were collected to conduct the tumor microenvironment detection analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically or cytologically confirmed locally advanced resectable gastric and gastro-oesophageal junction adenocarcinoma.
Key inclusion criteria (6 listed)
- Histologically or cytologically confirmed locally advanced resectable gastric and gastro-oesophageal junction adenocarcinoma at the stage of cT2-T4aNxM0 (AJCC 8th) without distant metastases and without infiltration of adjacent structures and organs.
- 18-75 years old.
- Willing to provide residual tumor tissues after routine clinical diagnosis for tumor microenvironment detection analysis.
- Patients agree to participate in the study and sign the informed consent.
- Patients need to receive perioperative drug therapy.
Key exclusion criteria (5 listed)
- 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.
- Patients with major cardiovascular and cerebrovascular diseases (such as congestive heart failure, unstable heart colic, atrial fibrillation, stroke, transient ischemic attack, etc.).
- Allergies or contraindications to common chemotherapy drugs, immunotherapy drugs or the ingredients.
- Women who are pregnant, breast-feeding.
- Other conditions the investigator believes that it is not suitable to participate in this study.
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
Major pathologic response (MPR) rate
Time frame: From the initiation date of first cycle to the date of surgery, an average of 10 weeks
Defined as <10% residual viable tumor cells in the resection specimen after neoadjuvant drug treatment.
3 secondary outcomes
Pathological complete response (pCR) rate
Time frame: From the initiation date of first cycle to the date of surgery, an average of 10 weeks
R0 resection rate
Time frame: From the initiation date of first cycle to the date of surgery, an average of 10 weeks
Disease-free Survival (DFS)
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- 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.
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 Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 30 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Major pathologic response (MPR) rate (time frame: From the initiation date of first cycle to the date of surgery, an average of 10 weeks). 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 NCT04850729, 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 30 May 2025.