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| Name | Class |
|---|---|
| Peking University International Hospital | OTHER |
| Chinese PLA General Hospital | OTHER |
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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:
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 were divided into 3 types: Type I (resectable type), Type II (potentially resectable type), Type III (unresectable type). The patients' general information, past medical history, imaging results, laboratory tests, surgical and systemic therapy details will be recorded and analysed. The 2-year overall survival (OS) will be recorded as the primary endpoint. The different therapies (surgery, chemotherapy and immunotherapy) of GCLM, the effects of different therapies on prognosis including OS of type I, II and III; R0 resection rate and diease free survival (DFS) of type I; successful conversion rate and R0 resection rate and events free survival (EFS) of type II will be recorded as secondary endpoints.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| observation | Other | This is an observational study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2-year OS | The primary study endpoint was two-year survival in patients | 2 years OS from diagnosed time to measured time or death |
| Measure | Description | Time Frame |
|---|---|---|
| OS of type I(questionnaires, phone calls, and outpatient follow-up.) | the effects of different therapeutic modalities (surgery, chemotherapy, immunotherapy, targeted therapy and others) on prognosis. | OS from diagnosed time to measured time or death(up to 5 years) |
| OS of type II (questionnaires, phone calls, and outpatient follow-up.) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) of disease by immunological drugs (Imaging information, pathology information from medical record.) | Degree of tumour response after treatment in all participants treated with applied immunological drugs. | Through study completion, an average of 2 year. |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hong qing Xi, PhD | Contact | 17330925741 | xihongqing301@163.com | |
| Lin Chen, PhD | Contact | 18101082801 | luting2023@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Beijing | Beijing Municipality | 100853 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39779263 | Derived | 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. |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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the effects of different therapeutic modalities (surgery, chemotherapy, immunotherapy, targeted therapy and others) on prognosis. |
| OS from diagnosed time to measured time or death(2 to 5 years) |
| OS of type III(questionnaires, phone calls, and outpatient follow-up.) | the effects of different therapeutic modalities (surgery, chemotherapy, immunotherapy, targeted therapy and others) on prognosis. | 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.) | DFS of type I. Disease-free survival time maintained after the participant has been saved by therapeutic measures.Especially in patients underwent radical surgery. | Through study completion, an average of 2 year. |
| R0 resection rate (pathological information from medical record.) | Proportion of all operated patients achieving radical resection. | Through study completion, an average of 2 year. |
| successful conversion therapy rate (pathological information and surgery information from medical record.) | Proportion of type II patients underwent radical surgery after systemic treatment. | Through study completion, an average of 2 year. |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |