An observational study in Gastric Cancer, sponsored by Nanfang Hospital, Southern Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-28.
Sponsored by Nanfang Hospital, Southern Medical University · Observational
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.
2,850 studies on the registry are indexed under Stomach Neoplasms; 863 are open to participants now.
This study's planned enrollment of 89 is below the median of 274 across 670 observational studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Nanfang Hospital, Southern Medical University is the lead sponsor of 480 studies on the registry; 212 are open to participants now.
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Patients with histologically or cytologically confirmed advanced gastric cancer.
Exclusion Criteria:
non-intervention
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.
Time frame: 4 years
Objective Response Rate (ORR)
Defined as the percentage of patients who had a best response of complete response (CR), or partial response (PR).
Time frame: 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.
Time frame: 4 years
Duration Of Response (DOR)
Defined as the time from first documented response to first documented tumor progression or death from any cause.
Time frame: 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).
Time frame: 4 years
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Nanfang Hospital, Southern Medical University