Clinical trial NCT06938451: Relationship Between FGF19 Overexpression and Disease Prognosis
Official title: A Real-world Study of FGF19 Overexpression Status and Treatment Outcome and Prognosis in Advanced Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hepatocellular Carcinoma (HCC)
Keywords: FGF19
hepatocellular carcinoma
HCC
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with HCC in the middle to late stages of the disease；Sufficient previous hepatocellular carcinoma tissue samples were available for immunohistochemical detection of FGF19

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: PFS
timeFrame: Enrollment until disease progression
measure: OS
timeFrame: Start of enrollment until death (from any cause)
Secondary outcomes:
measure: ORR
timeFrame: Time to enrollment until disease downsizing
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
Study officials:
affiliation: Beijing Tsinghua Changgeng Hospital
name: ZHAOYING Resident physician, phD
role: PRINCIPAL_INVESTIGATOR
References: