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

A Clinical Prospective Study to Validate a Risk Scoring Model for the Hepatic Metastases From Gastric Cancer After Curative Surgery

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 therapy. In order to further validate the clinical applicability of abovementioned model, investigators designed this prospective study, which also included patients who received neoadjuvant therapy before surgery, with the aim of exploring the applicability of the risk scoring model to this group of patients.

Study Overview

• Status: Completed
• Conditions: Gastric Cancer; Predictive Cancer Model; Hepatic Metastasis

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 curative gastrectomy and the predicted outcomes of the risk scoring model, in order to assess the clinical applicability of the model. In addition, analyses were performed to compare the differences in the risk of hepatic metastasis and the time interval of occurrence between patients who did not receive neoadjuvant therapy and those who received neoadjuvant therapy, as well as between patients with different outcomes after receiving neoadjuvant therapy (TRG 0-1 vs. TRG 2-3 in postoperative pathology).

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• China
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300060
      • Cancer Hospital of Tianjin Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patietns who were diagnosed with gastric cancer pathologically and underwent curative gastrectomy.

Description

Inclusion Criteria:

1. Received curative gastrectomy (D2 lymph node dissection);
2. Gastric cancer without distant organ metastasis, distant lymph node metastasis and peritoneal implantation (M0) confirmed by postoperative pathology;
3. 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;
4. No history of intraperitoneal chemotherapy;
5. No other serious concomitant diseases with satisfactory organ function;
6. No history of other malignant tumors;
7. Comply with the protocol during the whole study period;
8. Sign informed consent and permission of withdraw in the whole study period;
9. Estimation the overall survival after surgery no less than 12 months;
10. Consent to analysis of clinicopathological data and prognostic follow up;
11. Karnofsky Performance Scores (KPS) more than 60.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
with HMGC; patients with gastric cancer who developed hepatic metastasis after curative gastrectomy
without HMGC; patients with gastric cancer who did not developed hepatic metastasis after curative gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hepatic metastasis	Postoperative telephone follow-up was performed in patients with gastric cancer undergoing curative gastrectomy to determine the occurrence of hepatic metastasis.	2 years after curative surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
interval between the surgery and hepatic metastasis	Postoperative telephone follow-up was performed in patients with gastric cancer undergoing curative gastrectomy to determine the interval between the gastrectomy and development of hepatic metastasis.	2 years after curative surgery

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): August 31, 2025
• Study Completion (Actual): August 31, 2025

Study Registration Dates

• First Submitted: August 29, 2023
• First Submitted That Met QC Criteria: August 29, 2023
• First Posted (Actual): September 5, 2023

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: DJY003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No