Status:
NOT_YET_RECRUITING
Prospective Observational Cohort Study
Lead Sponsor:
Lin Chen
Collaborating Sponsors:
Peking University International Hospital
Chinese PLA General Hospital
Conditions:
Gastric Cancer
Liver Metastases
Eligibility:
All Genders
18+ years
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....
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 15 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
1326 Patients enrolled
Trial Details
Trial ID
NCT06493448
Start Date
July 15 2024
End Date
December 31 2028
Last Update
July 10 2024
Active Locations (1)
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1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853