Biomarkers and Molecular Mechanism Study of Hepatocellular Carcinoma After Radical Resection and Conversion Therapy

Blood samples will be tested to identify circulating tumor DNA and plasma protein levels to potentially improve prediction of long term prognosis and guide treatment options of patients with hepatocellular carcinoma underwent surgical resection.

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Diagnostic test: ctDNA monitoring; Diagnostic test: Plasma proteomic analysis

• Study Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: Huichuan Sun; Phone Number: +86-21-64041990; Email: sun.huichuan@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai, China, 200032
    • Recruiting
    • Zhongshan Hospital Fudan University
    • Contact: Hui-Chuan Sun; Phone Number: 86+13701922065; Email: sun.huichuan@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will enroll male and female subjects with HCC treated with definitive surgery,with or without neoadjuvant therapy.

Description

Inclusion Criteria:

• Patients with a first diagnosis of HCC.
• Patients with HCC who are to undergo surgical treatment, with or without neoadjuvant therapy.
• Ability to obtain tissue sample for ctDNA analysis and detectable baseline ctDNA level.

Exclusion Criteria:

• Patients with secondary liver cancer, or intrahepatic cholangiocarcinoma.
• Any other concurrent malignancy.
• History of organ transplant or hepatic encephalopathy.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between ctDNA level and recurrence-free survival (RFS)	ctDNA measurements will be made at baseline and 1 months, 3 months, 6 months, 12 months after surgery. RFS will be assessed by standard radiographic imaging.	1 years
Correlation between specific plasma protein expression level and recurrence-free survival (RFS)	plasma proteomic measurements will be made at baseline and 1 months, 3 months, 6 months, 12 months after surgery. RFS will be assessed by standard radiographic imaging.	1 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between tumor mutation numbers and recurrence-free survival (RFS)	Patients with available tumor tissues were sequenced to identify their specific tumor variants.The correlation of mutation numbers and RFS will be analysis.	1 years

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2024
• Primary Completion (Estimated): May 20, 2025
• Study Completion (Estimated): May 20, 2026

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 21, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 23, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: B2024-108R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No