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

Recruiting

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT06382103
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-15
• Study First Submitted QC: 2024-04-21
• Study First Posted: 2024-04-24
• Study Start: 2024-05-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-23
• Last Update Posted: 2025-03-26
• Primary Completion: 2025-05-20
• Study Completion: 2026-05-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between ctDNA level and recurrence-free survival (RFS)	1 years	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.
Correlation between specific plasma protein expression level and recurrence-free survival (RFS)	1 years	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zhongshan Hospital Fudan University; 🇨🇳 Shanghai, China