Prospective Observational Cohort Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: observation.
- Who it may be relevant to
- Registry conditions: Gastric Cancer, Liver Metastases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Observational Study of Gastric Cancer Synchronous Liver Metastases: a Multi-centre, Noninterventional, Cohort Study
Overview
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.
Interventions
- Other observation
This is an observational study.
Primary outcome measures
- 2-year OS [Time frame: 2 years OS from diagnosed time to measured time or death]
Secondary outcome measures (6)
- OS of type I（questionnaires, phone calls, and outpatient follow-up.） [Time frame: OS from diagnosed time to measured time or death（up to 5 years）]
- OS of type II （questionnaires, phone calls, and outpatient follow-up.） [Time frame: OS from diagnosed time to measured time or death（2 to 5 years）]
- OS of type III（questionnaires, phone calls, and outpatient follow-up.） [Time frame: OS from diagnosed time to measured time or death（no more than 2 years）]
- DFS of type I（questionnaires, phone calls, and outpatient follow-up.） [Time frame: Through study completion, an average of 2 year.]
- R0 resection rate (pathological information from medical record.) [Time frame: Through study completion, an average of 2 year.]
- successful conversion therapy rate (pathological information and surgery information from medical record.) [Time frame: Through study completion, an average of 2 year.]
Eligibility criteria
Inclusion criteria
- aged ≥18 years
- gastric primary lesions confirmed by pathology and liver metastases confirmed by pathology or imaging (before, during, or after initial treatment)
- expected survival time of ≥ 12 weeks
- Eastern Cooperative Oncology Group Physical Status Score (ECOG PS score) of 0-2
- signed informed consent
- good compliance and ability to complete regular follow-up
Exclusion criteria
- heterochronous liver metastases
- multi-centra clinics with significant missing case information
- diagnosed, suspected or active autoimmune disease
- history of immunodeficiency
- history of allogeneic organ and haematopoietic stem cell transplantation
- pregnant or breastfeeding female patients
- uncontrolled co-morbidities, including but not limited to:
- a.HIV-infected (HIV-positive) patients
- b.severe infections that are active or poorly controlled clinically
- c.evidence of severe or uncontrolled systemic disease
- \- severe psychiatric disease
- \- severe neurological disease
- \- epilepsy
- \- dementia
- \- unstable or uncompensated respiratory
- \- cardiovascular
- \- hepatic disease
- \- renal disease
- \- uncontrolled hypertension
- Abnormal coagulation in people with active bleeding or new thrombotic disease, on therapeutic doses of anticoagulants, or with bleeding tendencies.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Chinese PLA General Hospital — Beijing
Publications
- Lu T, Gao Y, Zhang G, Zhang H, Chen Z, Liu Y, Chen L, Xi H. Gastric cancer liver metastases in China: a real-world, multicentre, prospective, observational cohort study protocol. BMJ Open. 2025 Jan 8;15(1):e086276. doi: 10.1136/bmjopen-2024-086276. PMID 39779263
Identifiers
NCT: NCT06493448 · XHongqing