Validation of a risk scoring model for liver metastases after gastric cancer surgery

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

This study is testing a scoring system to see if it can accurately predict the risk of liver cancer spreading after surgery in patients who had their stomach removed for gastric cancer.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Tianjin Medical University Cancer Institute and Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Tianjin, 天津)
• Trial ID: NCT06023966 on ClinicalTrials.gov

What this trial studies

This prospective observational study aims to validate a previously established risk scoring model that predicts the occurrence of postoperative hepatic metastases in patients who have undergone curative gastrectomy. The study includes patients who received neoadjuvant therapy prior to surgery, allowing for a comprehensive analysis of the model's applicability across different patient groups. Data will be collected to compare actual patient outcomes with the model's predictions, focusing on the risk of hepatic metastasis and the timing of its occurrence. The study is conducted at a single center, ensuring a controlled environment for data collection and analysis.

Who should consider this trial

Good fit: Ideal candidates are patients who have undergone curative gastrectomy for gastric cancer without distant metastasis and have a Karnofsky Performance Score above 60.

Not a fit: Patients with pre-existing hepatic tumors, chronic liver diseases, or those who have undergone intraperitoneal chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the ability to predict liver metastases in gastric cancer patients, leading to improved postoperative management and outcomes.

How similar studies have performed: Previous studies have shown promise in developing predictive models for cancer outcomes, but this specific approach is novel in its focus on hepatic metastasis after gastric surgery.

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.

Where this trial is running

Tianjin, 天津

• Cancer Hospital of Tianjin Medical University — Tianjin, 天津, China (Recruiting)

Study contacts

• Study coordinator: Jingyu Deng, M.D.

Conditions Predictive Cancer Model; Hepatic Metastasis; Gastric Cancer