Relationship Between FGF19 Overexpression and Disease Prognosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma (HCC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Real-world Study of FGF19 Overexpression Status and Treatment Outcome and Prognosis in Advanced Hepatocellular Carcinoma
Overview
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.
Interventions
- Other
This is an observational study and does not involve an intervention
Primary outcome measures
- PFS [Time frame: Enrollment until disease progression]
- OS [Time frame: Start of enrollment until death (from any cause)]
Secondary outcome measures (1)
- ORR [Time frame: Time to enrollment until disease downsizing]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
China · 1 center
- Beijing Tsinghua Changgung Hospital — Beijing
Identifiers
NCT: NCT06938451 · V1.0 20250309