Relationship Between Standard Treatment Efficacy and The Tumor Microenvironment in Advanced Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

An Observational Study of Relationship Between Standard Treatment Efficacy and The Tumor Microenvironment in Advanced Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04850716
• Other study ID #: NFEC-2019-264
• Status: Recruiting
• Start date: April 27, 2021
• Est. completion date: November 1, 2023

Study information

• Verified date: March 2023
• Source: Nanfang Hospital of Southern Medical University
• Contact: Wangjun Liao, MD, PhD
• Phone: 86-20-62787731
• Email: nfyyliaowj[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 89
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Histologically or cytologically confirmed advanced gastric cancer.

2. Willing to receive anti-tumor drug treatment.

3. Willing to provide residual tumor tissues after routine clinical diagnosis for tumor microenvironment detection analysis.

4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.

5. At least one measurable lesion or non-measurable but evaluable as defined by RECIST 1.1.

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Other:
• non-intervention
non-intervention

Locations

Country	Name	City	State
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	4 years
Secondary	Duration Of Response (DOR)	Defined as the time from first documented response to first documented tumor progression or death from any cause.	4 years
Secondary	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