Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06157060

Prediction of Hepatocellular Carcinoma Recurrence After Curative Treatment by Longitudinal Monitoring MRD Based on ctDNA

This study will conduct a prospective cohort study to verify the predictive value of ctDNA-MRD longitudinal monitoring model in predicting postoperative recurrence, verify whether ctDNA-MRD longitudinal monitoring model can indicate recurrence earlier than imaging examination, and explore the feasibility of guiding adjuvant therapy after curative treatment based on this model.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Sixth Affiliated Hospital of South China University of Technology, Foshan, Guangdong, China

Loading trial locations.

About this study

The recurrence rate of hepatocellular carcinoma after curative treatment is high, and the minimal residual disease(MRD) in patients is the major cause of liver cancer recurrence, and the MRD is an important basis for the decision of adjuvant therapy after curative treatment. Previous studies have confirmed that circulating tumor DNA(ctDNA)-MRD monitoring model can accurately predict the recurrence of hepatocellular carcinoma patients. It was also found in retrospective analysis that tumor free survival was significantly prolonged after ctDNA-positive treatment for hepatocellular carcinoma after resection. This study will conduct a prospective cohort study to verify the predictive value of ctDNA-MRD longitudinal monitoring model in predicting postoperative recurrence, verify whether ctDNA-MRD longitudinal monitoring model can indicate recurrence earlier than imaging examination, and explore the feasibility of guiding adjuvant therapy after curative treatment based on this model.This study is to verify the predictive value of ctDNA-MRD longitudinal monitoring model in predicting postoperative recurrence.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female patients aged 18-75 years;
  • Preoperative imaging examination diagnosed hepatocellular carcinoma (BCLC) stage 0 / stage A/stage B, eligible for radical surgery;
  • ECOG physical status score is 0-1;
  • Child-Pugh score is 5-6 points (Level A);
  • Not received any anti-tumor therapy;
  • Laboratory tests were at normal levels within 7 days before enrollment.

Exclusion criteria

  • Patient can't provide blood samples for ctDNA testing;
  • Patient with two or more types of tumors at the same time;
  • Non-primary liver lesions;
  • Pregnant or lactating women;
  • Patient with a history of other malignant tumors within the past 5 years or at the same time, except cured skin basal cell carcinoma, cervical carcinoma in situ and thyroid papillary carcinoma;
  • Patient with serious heart disease;
  • Other conditions deemed unsuitable for inclusion by the researcher.

Treatment and study plan

circulating tumor DNA

Diagnostic Test

blood sample and tissue specimen for circulating tumor DNA will be done to patient with hepatocellular carcinoma

Primary outcomes

  1. 2-year recurrence-free survival rate

    Time frame: 2 years

    percentage of recurrence-free survival 2 years after surgery

Secondary outcomes

  1. Correlation between ctDNA-MRD status dynamic changes and relapse

    Time frame: 2 years

    Correlation between ctDNA-MRD status dynamic changes and relapse

Study contacts

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

Cheng Zhang

CONTACT

[email protected]

13242781120

Mingxin Pan, Prof.

CONTACT

[email protected]

+8618928918216

Sponsors and collaborators

Lead sponsor

Zhujiang Hospital

Other

Registry information

Official study title

Prediction of Hepatocellular Carcinoma Recurrence After Curative Treatment by Longitudinal Monitoring Minimal Residual Disease Based on Circulating Tumor DNA

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Dec 5, 2023
Registry last updated
Mar 20, 2026

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.

Published trials that share one or more normalized conditions with this study.