NCT04574245

Brief Summary

This multi-institutional retrospective cohort study aimed to describe and analyze the overall clinical characteristics, therapeutic status and prognosis pattern of gastric cancer liver metastasis (GCLM) in China.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
10.7 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

October 5, 2022

Status Verified

October 1, 2022

Enrollment Period

12.9 years

First QC Date

September 23, 2020

Last Update Submit

October 3, 2022

Conditions

Stomach NeoplasmsNeoplasm Metastasis

Keywords

PrognosisMultidisciplinary treatmentC-GCLM ClassificationGastric cancerLiver metastasis

Outcome Measures

Primary Outcomes (3)

  • 1-year overall survival

    The proportion (%) of gastric cancer liver metastasis patients that survived beyond one-year follow-up period.

    2011/01/01-2020/12/31

  • 3-year overall survival

    The proportion (%) of gastric cancer liver metastasis patients that survived beyond three-year follow-up period.

    2011/01/01-2021/12/31

  • 5-year overall survival

    The proportion (%) of gastric cancer liver metastasis patients that survived beyond five-year follow-up period.

    2011/01/01-2021/12/31

Secondary Outcomes (4)

  • The incidence of gastric cancer liver metastasis cases

    2010/01/01-2019/12/31

  • The proportion for synchronous and metachronous liver metastases cases

    2010/01/01-2019/12/31

  • The survival of patients that recieved different therapeutic methods

    2010/01/01-2019/12/31

  • The prognostic predictive value for patients with different C-GCLM classification

    2010/01/01-2019/12/31

Study Arms (3)

Resectable group

Procedure: Gastrectomy; Hepatectomy

Potentially resectable group

Unresectable group

Interventions

Gastrectomy; HepatectomyPROCEDURE
Also known as: Radiofrequency ablation, Chemotherapy, Immunotherapy, Target therapy
Resectable group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All eligible in-hospital gastric cancer liver metastases cases.

You may qualify if:

  • Gastric cancer liver metastases cases aged over 18 years old;
  • Primary gastric carcinoma (including different histopathological types) confirmed by biopsy or surgery (pre-, intra- or post- treatment);
  • In hospital cases between 2020/01/01 to 2019/12/3.

You may not qualify if:

  • Poor compliance to treatment or lost to follow-up;
  • Gross loss of clinical data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Surgery Institute, China PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Related Publications (1)

  • Zhang K, Chen L. Chinese consensus on the diagnosis and treatment of gastric cancer with liver metastases. Ther Adv Med Oncol. 2020 Feb 20;12:1758835920904803. doi: 10.1177/1758835920904803. eCollection 2020.

    PMID: 32127925BACKGROUND

MeSH Terms

Conditions

Stomach NeoplasmsNeoplasm Metastasis

Interventions

GastrectomyHepatectomyRadiofrequency AblationDrug TherapyImmunotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, OperativeRadiofrequency TherapyTherapeuticsAblation TechniquesImmunomodulationBiological Therapy

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

September 23, 2020

First Posted

October 5, 2020

Study Start

January 1, 2010

Primary Completion

November 30, 2022

Study Completion

December 31, 2022

Last Updated

October 5, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)