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

NCT ID: NCT06023966

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-08-31

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 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.

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).

Conditions

Predictive Cancer Model; Hepatic Metastasis; Gastric Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

with HMGC

patients with gastric cancer who developed hepatic metastasis after curative gastrectomy

No interventions assigned to this group

without HMGC

patients with gastric cancer who did not developed hepatic metastasis after curative gastrectomy

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cancer Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

DJY003

Identifier Type: -

Identifier Source: org_study_id