Prospective Observational Cohort Study

Официальное название

Prospective Observational Study of Gastric Cancer Synchronous Liver Metastases: a Multi-centre, Noninterventional, Cohort Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое observation
  This is an observational study.

Первичные конечные точки

• 2-year OS [Срок оценки: 2 years OS from diagnosed time to measured time or death]

Вторичные конечные точки (6)

• OS of type I（questionnaires, phone calls, and outpatient follow-up.） [Срок оценки: OS from diagnosed time to measured time or death（up to 5 years）]
• OS of type II （questionnaires, phone calls, and outpatient follow-up.） [Срок оценки: OS from diagnosed time to measured time or death（2 to 5 years）]
• OS of type III（questionnaires, phone calls, and outpatient follow-up.） [Срок оценки: 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.） [Срок оценки: Through study completion, an average of 2 year.]
• R0 resection rate (pathological information from medical record.) [Срок оценки: Through study completion, an average of 2 year.]
• successful conversion therapy rate (pathological information and surgery information from medical record.) [Срок оценки: Through study completion, an average of 2 year.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Chinese PLA General Hospital — Пекин

Публикации

• 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. PMID 39779263

Идентификаторы

NCT: NCT06493448 · XHongqing

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗