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NCT Number: NCT06382103

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Hospital Fudan University

Shanghai, 200032, China

Location status: Recruiting

Location contact

Hui-Chuan Sun

CONTACT

[email protected]

86+13701922065

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Correlation between ctDNA level and recurrence-free survival (RFS)

    Time frame: 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.

  2. Correlation between specific plasma protein expression level and recurrence-free survival (RFS)

    Time frame: 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 outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Huichuan Sun

CONTACT

[email protected]

+86-21-64041990

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 24, 2024
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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