Prospective Observational Cohort Study

NCT ID: NCT06493448

Last Updated: 2024-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1326 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-15

Study Completion Date

2028-12-31

Brief Summary

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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:

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

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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.

Conditions

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Gastric Cancer Liver Metastases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort A

Type I liver metastases, resectable type, with the option of direct surgical resection or preoperative systemic therapy

observation

Intervention Type OTHER

This is an observational study.

Cohort B

Type II liver metastases, potentially resectable type, preoperative systemic therapy is applied to gain the chance of surgery

observation

Intervention Type OTHER

This is an observational study.

Cohort C

Type III liver metastases, systemic treatment according to recommended guidelines and patient characteristics

observation

Intervention Type OTHER

This is an observational study.

Interventions

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observation

This is an observational study.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University International Hospital

OTHER

Sponsor Role collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role collaborator

Lin Chen

OTHER

Sponsor Role lead

Responsible Party

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Lin Chen

Director and Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Hong qing Xi, PhD

Role: CONTACT

17330925741

Lin Chen, PhD

Role: CONTACT

18101082801

Facility Contacts

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Hong qing Xi, PhD

Role: primary

800-555-5555

Lin Chen, PhD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 39779263 (View on PubMed)

Other Identifiers

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XHongqing

Identifier Type: -

Identifier Source: org_study_id

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