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

NCT06382103 | Recruiting

• 1 other identifier: B2024-108R
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Correlation between tumor mutation numbers and recurrence-free survival (RFS)

  1 years

Interventions

ctDNA monitoring DIAGNOSTIC_TEST

The ctDNA level will be measured using tumor-informed (Signatera platform) and tumor-naived (fragmentomes measurement) assay.

Plasma proteomic analysis DIAGNOSTIC_TEST

plasma protein level will be measured via Proximity Extension Assay and LC-MS based proteomic analysis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, 200032, China

RECRUITING

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

Central Study Contacts

Huichuan Sun

CONTACT

+86-21-64041990; sun.huichuan@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 24, 2024
• Study Start: May 15, 2024
• Primary Completion: May 20, 2025
• Study Completion (Estimated): May 20, 2026
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)