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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-intervention | Other | non-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Defined as the percentage of patients who had a best response of complete response (CR), or partial response (PR). | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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.
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Patients with histologically or cytologically confirmed advanced gastric cancer.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wangjun Liao, MD, PhD | Contact | 86-20-62787731 | nfyyliaowj@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital, Southern Medical University | Recruiting | Guangzhou | Guangdong | 510515 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39089261 | Derived | 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. |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 4 years |
| Duration Of Response (DOR) | Defined as the time from first documented response to first documented tumor progression or death from any cause. | 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). | 4 years |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |