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Prospective observational study of gastric cancer synchronous liver metastases

Prospective observational study of gastric cancer synchronous liver metastases

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400083955
Enrollment
Unknown
Registered
2024-05-08
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric cancer with liver metastases

Interventions

Cohort A/ Cohort B/ Cohort C:None

Sponsors

PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. patients aged =18 years with GCLM with or without other distant metastasis. 2. gastric primary lesions confirmed by pathology and liver metastases confirmed by pathology or imaging (before, during, or after initial treatment). 3. GCLM diagnosed between July 1, 2024 and December 31, 2026. 4. expected survival time of = 12 weeks. 5. a score of 0-2 according to the Eastern Cooperative Oncology Group Physical Status Score (ECOG PS score). 6. signed informed consent. 7. good compliance and ability to complete regular follow-up.

Exclusion criteria

Exclusion criteria: 1. heterochronous liver metastases. 2. multi-center clinics with serious missing case information. 3. diagnosed or suspected autoimmune disease, or in active stage. 4. known history of primary immunodeficiency. 5. known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 6. pregnant or breastfeeding female patients. 7. uncontrolled co-morbidities, including but not limited to: 1)HIV-infected (HIV-positive) patients, 2)severe infections that are active or poorly controlled clinically, 3)evidence of the presence of severe or uncontrolled systemic disease (e.g., severe psychiatric, neurologic disease, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, hepatic or renal disease, uncontrolled hypertension [Refers to hypertension that is still greater than or equal to CTCAE level 2 after drug treatment]. 4) Abnormal coagulation (INR > 1.5 x ULN, APTT > 1.5 x ULN) in those with active bleeding or new thrombotic disease who are taking therapeutic doses of anticoagulant medication or who have a bleeding tendency.

Design outcomes

Primary

MeasureTime frame
2-year OS;

Secondary

MeasureTime frame
OS;R0 resection rate;DFS;convertion successful rate;EFS;

Countries

China

Contacts

Public ContactCHEN Lin

Department of General Surgery, First Medical Center, General Hospital of the PLA

xihongqing@126.com+86 158 1023 6876

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026