Prospective Observational Cohort Study

July 1, 2024 updated by: Lin Chen

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

1326

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Chinese PLA General Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hong qing Xi, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort A
Type I liver metastases, resectable type, with the option of direct surgical resection or preoperative systemic therapy
Other: observation
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
Other: observation
This is an observational study.
Cohort C
Type III liver metastases, systemic treatment according to recommended guidelines and patient characteristics
Other: observation
This is an observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year OS
Time Frame: 2 years OS from diagnosed time to measured time or death
The primary study endpoint was two-year survival in patients
2 years OS from diagnosed time to measured time or death

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS of type I（questionnaires, phone calls, and outpatient follow-up.）
Time Frame: OS from diagnosed time to measured time or death（up to 5 years）
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.）
Time Frame: OS from diagnosed time to measured time or death（2 to 5 years）
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.）
Time Frame: OS from diagnosed time to measured time or death（no more than 2 years）
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.）
Time Frame: Through study completion, an average of 2 year.
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.)
Time Frame: Through study completion, an average of 2 year.
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.)
Time Frame: Through study completion, an average of 2 year.
Proportion of type II patients underwent radical surgery after systemic treatment.
Through study completion, an average of 2 year.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR) of disease by immunological drugs (Imaging information, pathology information from medical record.)
Time Frame: Through study completion, an average of 2 year.
Degree of tumour response after treatment in all participants treated with applied immunological drugs.
Through study completion, an average of 2 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lin Chen

Collaborators

Chinese PLA General Hospital
Peking University International Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 15, 2024

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

April 22, 2024

First Submitted That Met QC Criteria

July 1, 2024

First Posted (Actual)

July 10, 2024

Study Record Updates

Last Update Posted (Actual)

July 10, 2024

Last Update Submitted That Met QC Criteria

July 1, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XHongqing

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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