Status:

COMPLETED

A Clinical Prospective Study to Validate a Risk Scoring Model for the HMGC After Curative Surgery

Lead Sponsor:

Tianjin Medical University Cancer Institute and Hospital

Conditions:

Predictive Cancer Model

Hepatic Metastasis

Eligibility:

All Genders

18-70 years

Brief Summary

A previous study of investigators established a risk scoring model for occurrence of postoperative hepatic metastases in patients who underwent curative gastrectomy directly without neoadjuvant therap...

Detailed Description

The study was a single-centre, prospective study. Prospectively collected data were used to analyze the consistency between the actual outcomes of patients with or without hepatic metastases after cur...

Eligibility Criteria

Inclusion

  • Received curative gastrectomy (D2 lymph node dissection);
  • Gastric cancer without distant organ metastasis, distant lymph node metastasis and peritoneal implantation (M0) confirmed by postoperative pathology;
  • No hepatic tumors and other occupying diseases, no chronic diseases such as cirrhosis and hepatitis, no hepatic schistosomiasis, no hepatic echinococcosis, no hepatic tuberculosis, and no severe fatty liver disease before the curative surgery;
  • No history of intraperitoneal chemotherapy;
  • No other serious concomitant diseases with satisfactory organ function;
  • No history of other malignant tumors;
  • Comply with the protocol during the whole study period;
  • Sign informed consent and permission of withdraw in the whole study period;
  • Estimation the overall survival after surgery no less than 12 months;
  • Consent to analysis of clinicopathological data and prognostic follow up;
  • Karnofsky Performance Scores (KPS) more than 60.

Exclusion

  • Special histological types of gastric cancer (neuroendocrine, squamous, squamous cell, hepatoid adenocarcinoma or others);
  • Gastro-esophageal junction cancer;
  • Severe congestive heart failure, frequent arrhythmia, or myocardial infarction within 12 months;
  • Immunosuppressive therapists for organ transplantation;
  • Seriously uncontrolled recurrent infection;
  • History of other malignancies;
  • No abilities of self-knowledge or mental disorders;
  • Combination of other serious diseases;
  • Concurrent participation in other clinical trials.

Key Trial Info

Start Date :

September 1 2023

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

August 31 2025

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT06023966

Start Date

September 1 2023

End Date

August 31 2025

Last Update

November 20 2025

Active Locations (1)

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Cancer Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China, 300060