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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06382103
• Other study ID #: B2024-108R
• Status: Not yet recruiting
• Start date: April 20, 2024
• Est. completion date: May 20, 2026

Study information

• Verified date: April 2024
• Source: Shanghai Zhongshan Hospital
• Contact: Huichuan Sun
• Phone: +86-21-64041990
• Email: sun.huichuan[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: May 20, 2026
• Est. primary completion date: May 20, 2025
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Diagnostic Test:
• ctDNA monitoring
The ctDNA level will be measured using tumor-informed (Signatera platform) and tumor-naived (fragmentomes measurement) assay.
• Plasma proteomic analysis
plasma protein level will be measured via Proximity Extension Assay and LC-MS based proteomic analysis

Locations

Country	Name	City	State
China	180 Fenglin Road	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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