Clinical trial · Observational
Prospective Observational Cohort Study
Prospective Observational Study of Gastric Cancer Synchronous Liver Metastases: a Multi-centre, Noninterventional, Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Liver Metastases | Gastric Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| observation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Cohort A
- description
- Type I liver metastases, resectable type, with the option of direct surgical resection or preoperative systemic therapy
- interventionNames
- Other: observation
- label
- Cohort B
- description
- Type II liver metastases, potentially resectable type, preoperative systemic therapy is applied to gain the chance of surgery
- interventionNames
- Other: observation
- label
- Cohort C
- description
- Type III liver metastases, systemic treatment according to recommended guidelines and patient characteristics
- interventionNames
- Other: observation
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDLu 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