Relationship Between FGF19 Overexpression and Disease Prognosis

NCT06938451 | Not Yet Recruiting

• 1 other identifier: V1.0 20250309
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

FGF19; hepatocellular carcinoma; HCC

Outcome Measures

Primary Outcomes (2)

• 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

  Enrollment until disease progression

• OS

  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

  Start of enrollment until death (from any cause)

Secondary Outcomes (1)

• ORR

  Time to enrollment until disease downsizing

Study Arms (1)

inspection team

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

Beijing Tsinghua Changgung Hospital

Beijing, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• ZHAOYING Resident physician, phD

  Beijing Tsinghua Changgeng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ZHAOYING Resident physician, phD

CONTACT

86+13810943515; zya03937@btch.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 22, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 22, 2025

Record last verified: 2025-03

Locations

CN (1)