Prospective Observational Cohort Study
Prospective Observational Study of Gastric Cancer Synchronous Liver Metastases: a Multi-centre, Noninterventional, Cohort Study
1 other identifier
observational
1,326
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2024
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2024
CompletedFirst Posted
Study publicly available on registry
July 10, 2024
CompletedStudy Start
First participant enrolled
July 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
July 10, 2024
July 1, 2024
2 years
April 22, 2024
July 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
2-year OS
The primary study endpoint was two-year survival in patients
2 years OS from diagnosed time to measured time or death
Secondary Outcomes (6)
OS of type I（questionnaires, phone calls, and outpatient follow-up.）
OS from diagnosed time to measured time or death（up to 5 years）
OS of type II （questionnaires, phone calls, and outpatient follow-up.）
OS from diagnosed time to measured time or death（2 to 5 years）
OS of type III（questionnaires, phone calls, and outpatient follow-up.）
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.）
Through study completion, an average of 2 year.
R0 resection rate (pathological information from medical record.)
Through study completion, an average of 2 year.
- +1 more secondary outcomes
Other Outcomes (1)
Objective response rate (ORR) of disease by immunological drugs (Imaging information, pathology information from medical record.)
Through study completion, an average of 2 year.
Study Arms (3)
Cohort A
Type I liver metastases, resectable type, with the option of direct surgical resection or preoperative systemic therapy
Cohort B
Type II liver metastases, potentially resectable type, preoperative systemic therapy is applied to gain the chance of surgery
Cohort C
Type III liver metastases, systemic treatment according to recommended guidelines and patient characteristics
Interventions
Eligibility Criteria
The main study population was: patients diagnosed with liver metastases from gastric cancer who met the inclusion and exclusion criteria in China. Patient care in various tertiary hospitals throughout the country.
You may qualify if:
- 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
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lin Chenlead
- Peking University International Hospitalcollaborator
- Chinese PLA General Hospitalcollaborator
Study Sites (1)
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Related Publications (1)
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: 39779263DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director and Clinical Professor
Study Record Dates
First Submitted
April 22, 2024
First Posted
July 10, 2024
Study Start
July 15, 2024
Primary Completion (Estimated)
July 30, 2026
Study Completion (Estimated)
December 31, 2028
Last Updated
July 10, 2024
Record last verified: 2024-07