Relationship Between FGF19 Overexpression and Disease Prognosis

Beijing Tsinghua Chang Gung Hospital

Status: Not yet enrolling

Conditions: Hepatocellular Carcinoma (HCC)

Study type: Observational

Funder types: Other

Identifiers

NCT06938451

V1.0 20250309

Details and patient eligibility

About

A real-world study of FGF19 overexpression status and treatment outcome and prognosis in advanced hepatocellular carcinoma

Full description

This is a real-world, single-arm, observational study to collect information on the diagnosis and prognosis of hepatocellular carcinoma patients with previous tissue samples in routine clinical practice, and to detect the expression of FGF19 expression in tissue samples, with a view to discovering prognostic and predictive markers for advanced hepatocellular carcinoma The treatment protocol of this study follows the clinical practice and does not set any limitations on the interventions for patients.

In this study, real-world liver tissue samples will be collected from patients with hepatocellular liver cancer after surgical resection, and the samples will be sent to a third-party pathology slice reviewer for review, and a report on the FGF19 expression results will be returned to the project team. Simultaneously collect clinical data of the patient.

According to the principle of clinical routine diagnosis and treatment, the patient's imaging data were collected, and the imaging of the 2-month period was evaluated, and whether the disease progressed was judged according to the RESCIST v1.1 standard. Every two months will be an observation cycle. Each subject will be followed from the first treatment until disease progression or change of drug regimen.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years on the day of signing the informed consent form
• Histologically or clinically confirmed diagnosis of intermediate to advanced HCC
• Adequate tissue samples of previous liver cancer
• Expected survival of more than 3 months

Exclusion criteria

• Fibrous laminae or sarcomatoid HCC or mixed HCC-ICC, or other rare non-HCC pathologic subtypes
• Other conditions that, in the opinion of the investigator, make participation in this trial inappropriate

Trial design

100 participants in 1 patient group

inspection team

Description:

Surgically resected liver tissue samples were sent to a third-party pathology slice reviewer for uniform reading, and a report on FGF19 expression results was issued and returned to the project team. The clinical data of the patient will be collected at the same time.