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

March 18, 2026 updated by: Zhujiang Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

255

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mingxin Pan, Prof.
  • Phone Number: +8618928918216
  • Email: pmxwxy@sohu.com

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Foshan, Guangdong, China
        • Recruiting
        • The Sixth Affiliated Hospital of South China University of Technology
        • Contact:
          • Weichao Liang, Prof.
          • Phone Number: 13590542927
        • Principal Investigator:
          • Weichao Liang
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
          • Rongping Guo, Prof.
          • Phone Number: 18819809988
        • Principal Investigator:
          • Rongping Guo, Prof.
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangdong Provincial Hospital of Traditional Chinese Medicine
        • Contact:
          • Junming He, Prof.
          • Phone Number: 13501538271
        • Principal Investigator:
          • Junming He, Prof.
      • Guangzhou, Guangdong, China, 510220
        • Recruiting
        • ZhuJiang Hospital of Southern Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mingxin Pan
      • Guangzhou, Guangdong, China
        • Recruiting
        • Affiliated Cancer Hospital and institute of Guangzhou Medical University
        • Contact:
          • Yinbing Wu, Prof.
          • Phone Number: 18620007296
        • Principal Investigator:
          • Yinbing Wu, Prof.
      • Guangzhou, Guangdong, China
        • Recruiting
        • Shunde Hospital of Southern Medical University
        • Contact:
          • Weidong Wang, Prof.
          • Phone Number: 13702835586
        • Principal Investigator:
          • Weidong Wang, Prof.
      • Shaoguan, Guangdong, China
        • Recruiting
        • Yuebei People's Hospital
        • Contact:
          • Qingsong Wu, Prof.
          • Phone Number: 13826368658

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient with hepatocellular carcinoma who can undergo radical surgical resection

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patient can't provide blood samples for ctDNA testing;
  2. Patient with two or more types of tumors at the same time;
  3. Non-primary liver lesions;
  4. Pregnant or lactating women;
  5. 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;
  6. Patient with serious heart disease;
  7. Other conditions deemed unsuitable for inclusion by the researcher.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient with hepatocellular carcinoma
Patient with hepatocellular carcinoma who can undergo radical resection
Diagnostic test: circulating tumor DNA
blood sample and tissue specimen for circulating tumor DNA will be done to patient with hepatocellular carcinoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year recurrence-free survival rate
Time Frame: 2 years
percentage of recurrence-free survival 2 years after surgery
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between ctDNA-MRD status dynamic changes and relapse
Time Frame: 2 years
Correlation between ctDNA-MRD status dynamic changes and relapse
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhujiang Hospital

Investigators

  • Principal Investigator: Mingxin Pan, Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2023

Primary Completion (Estimated)

November 20, 2026

Study Completion (Estimated)

November 30, 2028

Study Registration Dates

First Submitted

November 23, 2023

First Submitted That Met QC Criteria

November 27, 2023

First Posted (Actual)

December 5, 2023

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-KY-232-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatocellular Carcinoma Resectable

Clinical Trials on circulating tumor DNA

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe