NCT06493448

Prospective Observational Cohort Study

Prospective Observational Study of Gastric Cancer Synchronous Liver Metastases: a Multi-centre, Noninterventional, Cohort Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,326 (estimated)
• Sponsor: Lin Chen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to learn about the overall disease status, diagnostic and therapeutic modalities, and prognosis of patients with gastric cancer liver metastasis(GCLM) in China. The investigators divided the participants into three groups( three types) of gastric cancer liver metastasis based onChinese c-GCLM classification system.The main question it aims to answer is: 1. How long do patients with GCLM live? 2. How different treatment modalities (surgery, chemotherapy, immunotherapy, targeted therapy and others) affect patients' prognosis of three type? All participants will be tracked for their physical condition.

Detailed description

This is a prospective, non-interventional, observational, multi-centre, real-world study designed to monitor the general condition, treatment pattern and prognosis of patients with GCLM. GCLM patients were divided into 3 types: Type I (resectable type), Type II (potentially resectable type), Type III (unresectable type). The patients' general information, past medical history, imaging results, laboratory tests, surgical and systemic therapy details will be recorded and analysed. The 2-year overall survival (OS) will be recorded as the primary endpoint. The different therapies (surgery, chemotherapy and immunotherapy) of GCLM, the effects of different therapies on prognosis including OS of type I, II and III; R0 resection rate and diease free survival (DFS) of type I; successful conversion rate and R0 resection rate and events free survival (EFS) of type II will be recorded as secondary endpoints. This study involving human participants were reviewed and approved by the Ethics Committee of Chinese PLA General Hospital (No.S2023-724-02) and will be conducted according to the guidelines of the Declaration of Helsinki. Study findings will be disseminated through international peer-reviewed journal articles as well as public, academic presentations at national and international conferences.

Conditions

• Gastric Cancer
• Liver Metastases

Interventions

Type	Name	Description
OTHER	observation	This is an observational study.

Timeline

• Start date: 2024-07-15
• Primary completion: 2026-07-30
• Completion: 2028-12-31
• First posted: 2024-07-10
• Last updated: 2024-07-10

Locations

1 site across 1 country: China