Clinical trial NCT06493448: Prospective Observational Cohort Study
Official title: Prospective Observational Study of Gastric Cancer Synchronous Liver Metastases: a Multi-centre, Noninterventional, Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Gastric Cancer
Liver Metastases
Keywords: gastric cancer
liver metastasis
observation
treatment
prognosis
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Peking University International Hospital
name: Chinese PLA General Hospital
First posted: 2024-07-10
Enrollment: 1326
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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. 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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 2-year OS
timeFrame: 2 years OS from diagnosed time to measured time or death
Secondary outcomes:
measure: OS of type I（questionnaires, phone calls, and outpatient follow-up.）
timeFrame: OS from diagnosed time to measured time or death（up to 5 years）
measure: OS of type II （questionnaires, phone calls, and outpatient follow-up.）
timeFrame: OS from diagnosed time to measured time or death（2 to 5 years）
measure: OS of type III（questionnaires, phone calls, and outpatient follow-up.）
timeFrame: OS from diagnosed time to measured time or death（no more than 2 years）
measure: DFS of type I（questionnaires, phone calls, and outpatient follow-up.）
timeFrame: Through study completion, an average of 2 year.
measure: R0 resection rate (pathological information from medical record.)
timeFrame: Through study completion, an average of 2 year.
measure: successful conversion therapy rate (pathological information and surgery information from medical record.)
timeFrame: Through study completion, an average of 2 year.
Other outcomes:
measure: Objective response rate (ORR) of disease by immunological drugs (Imaging information, pathology information from medical record.)
timeFrame: Through study completion, an average of 2 year.
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
References: