Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Location contact
Hong qing Xi, PhD
CONTACT
Hong qing Xi, PhD
PRINCIPAL_INVESTIGATOR
Lin Chen, PhD
CONTACT
NCT Number: NCT06493448
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Beijing, Beijing Municipality, 100853, China
Hong qing Xi, PhD
CONTACT
Hong qing Xi, PhD
PRINCIPAL_INVESTIGATOR
Lin Chen, PhD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This is an observational study.
Time frame: 2 years OS from diagnosed time to measured time or death
The primary study endpoint was two-year survival in patients
Time frame: OS from diagnosed time to measured time or death(up to 5 years)
the effects of different therapeutic modalities (surgery, chemotherapy, immunotherapy, targeted therapy and others) on prognosis.
Time frame: OS from diagnosed time to measured time or death(2 to 5 years)
the effects of different therapeutic modalities (surgery, chemotherapy, immunotherapy, targeted therapy and others) on prognosis.
Time frame: OS from diagnosed time to measured time or death(no more than 2 years)
the effects of different therapeutic modalities (surgery, chemotherapy, immunotherapy, targeted therapy and others) on prognosis.
Time frame: Through study completion, an average of 2 year.
DFS of type I. Disease-free survival time maintained after the participant has been saved by therapeutic measures.Especially in patients underwent radical surgery.
Time frame: Through study completion, an average of 2 year.
Proportion of all operated patients achieving radical resection.
Time frame: Through study completion, an average of 2 year.
Proportion of type II patients underwent radical surgery after systemic treatment.
Time frame: Through study completion, an average of 2 year.
Degree of tumour response after treatment in all participants treated with applied immunological drugs.
Contact information is provided by the study sponsor or research team.
Hong qing Xi, PhD
CONTACT
Lin Chen, PhD
CONTACT
Lin Chen
Other
Prospective Observational Study of Gastric Cancer Synchronous Liver Metastases: a Multi-centre, Noninterventional, Cohort Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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