Hepatocellular Carcinoma (HCC)
Conditions
Keywords
FGF19, hepatocellular carcinoma, HCC
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.
Interventions
None listed
Sponsors
Beijing Tsinghua Chang Gung Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | Enrollment until disease progression | PFS was calculated from the date of randomization to the date of the first documented disease progression, with no time constraints involved, marked by the appearance of disease progression |
| OS | Start of enrollment until death (from any cause) | Observation until death from the beginning of participation in the study observation until death from any cause, no time frame limitations were involved. Calculation of OS based on time of death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | Time to enrollment until disease downsizing | Proportion of patients whose tumor volume shrinks to a preset value and remains unchanged for a given period of time, total study duration 36 months, ORR observation period within 36 months |
Countries
China
Contacts
Primary ContactZHAOYING Resident physician, phD
Outcome results
None listed