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NCT Number: NCT06493448

Prospective Observational 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

observation

Other

This is an observational study.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hong qing Xi, PhD

CONTACT

[email protected]

17330925741

Lin Chen, PhD

CONTACT

[email protected]

18101082801

Sponsors and collaborators

Lead sponsor

Lin Chen

Other

Collaborators

  • Chinese PLA General Hospital
  • Peking University International Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Jul 10, 2024
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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