Relationship Between FGF19 Overexpression and Disease Prognosis

N/ANot Yet RecruitingNCT06938451

Beijing Tsinghua Chang Gung Hospital100 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Hepatocellular Carcinoma (HCC)

Interventions

OTHER

This is an observational study and does not involve an intervention

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Beijing Tsinghua Changgung Hospital

Beijing, China

Outcomes

Primary Outcomes

PFS

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

Time frame: Enrollment until disease progression

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

Time frame: Start of enrollment until death (from any cause)

Secondary Outcomes

ORR

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

Time frame: Time to enrollment until disease downsizing

Central Contacts

ZHAOYING Resident physician, phD

CONTACT

86+13810943515 zya03937@btch.edu.cn

Data from ClinicalTrials.gov

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