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

NCT04850716 | Unknown

• 1 other identifier: NFEC-2019-264
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Cancer

Keywords

Gastric Cancer; Tumor Microenvironment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Objective Response Rate (ORR)

  4 years

• Overall Survival (OS)

  4 years

• Duration Of Response (DOR)

  4 years

• Disease Control Rate (DCR)

  4 years

Interventions

non-intervention OTHER

non-intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with histologically or cytologically confirmed advanced gastric cancer.

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Wangjun Liao, MD, PhD

CONTACT

86-20-62787731; nfyyliaowj@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2021
• First Posted: April 20, 2021
• Study Start: April 27, 2021
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)