Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
1326 participants
OBSERVATIONAL
2024-07-15
2028-12-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort A
Type I liver metastases, resectable type, with the option of direct surgical resection or preoperative systemic therapy
observation
This is an observational study.
Cohort B
Type II liver metastases, potentially resectable type, preoperative systemic therapy is applied to gain the chance of surgery
observation
This is an observational study.
Cohort C
Type III liver metastases, systemic treatment according to recommended guidelines and patient characteristics
observation
This is an observational study.
Interventions
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observation
This is an observational study.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Peking University International Hospital
OTHER
Chinese PLA General Hospital
OTHER
Lin Chen
OTHER
Responsible Party
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Lin Chen
Director and Clinical Professor
Locations
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Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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XHongqing
Identifier Type: -
Identifier Source: org_study_id
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