Hepatocellular Carcinoma ResectableNCT06157060
Prediction of Hepatocellular Carcinoma Recurrence After Curative Treatment by Longitudinal Monitoring MRD Based on ctDNA
An observational study of Hepatocellular Carcinoma Resectable, run by Zhujiang Hospital at 7 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma Resectable
- What is being tested?
- circulating tumor DNA
- How many people
- 255 participants
- Where
- 7 sitesChina
- Study dates
- 20 Nov 2023to 30 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with hepatocellular carcinoma who can undergo radical surgical resection
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
The Sixth Affiliated Hospital of South China University of Technology
Foshan, Guangdong
Weichao Liang, Prof., 13590542927
Weichao Liang
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510220
Mingxin Pan, Prof., 18928918216, pmxwxy@sohu.com
Cheng Zhang, Dr., 13242781120, 754167410@qq.com
- Recruiting
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, Guangdong
Yinbing Wu, Prof., 18620007296
Yinbing Wu, Prof.
- Recruiting
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong
Junming He, Prof., 13501538271
Junming He, Prof.
- Recruiting
Shunde Hospital of Southern Medical University
Guangzhou, Guangdong
Weidong Wang, Prof., 13702835586
Weidong Wang, Prof.
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Rongping Guo, Prof., 18819809988
Rongping Guo, Prof.
- Recruiting
Yuebei People's Hospital
Shaoguan, Guangdong
Qingsong Wu, Prof., 13826368658
About this study
Official title: 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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma Resectable
- Being tested
- circulating tumor DNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
circulating tumor DNADiagnostic test
blood sample and tissue specimen for circulating tumor DNA will be done to patient with hepatocellular carcinoma
| Study group | Role | What they receive |
|---|---|---|
| Patient with hepatocellular carcinoma | Patient with hepatocellular carcinoma who can undergo radical resection Receives: Diagnostic Test: circulating tumor DNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year recurrence-free survival rate
percentage of recurrence-free survival 2 years after surgery
Measured: 2 years
Secondary outcomes (1)
Correlation between ctDNA-MRD status dynamic changes and relapse
Correlation between ctDNA-MRD status dynamic changes and relapse
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start20 Nov 2023
- Primary completion20 Nov 2026 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma ResectableStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 255 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mingxin Pan, Principal investigator, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157060
- Sponsor's protocol ID
- 2023-KY-232-01
- Status last verified
- Mar 2026
- First submitted
- 23 Nov 2023
- Last updated
- 20 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Hepatocellular Carcinoma Recurrence After Curative Treatment by Longitudinal Monitoring Minimal Residual Disease Based on Circulating Tumor DNA
- ClinicalTrials.gov ID
- NCT06157060
- Acronym / sponsor ID
- 2023-KY-232-01
- Conditions
- Hepatocellular Carcinoma Resectable
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 20 Nov 2026 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 5 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with hepatocellular carcinoma | – | Diagnostic Test: circulating tumor DNAPatient with hepatocellular carcinoma who can undergo radical resection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with hepatocellular carcinoma who can undergo radical surgical resection
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| circulating tumor DNAblood sample and tissue specimen for circulating tumor DNA will be done to patient with hepatocellular carcinoma | Diagnostic test | Patient with hepatocellular carcinoma |
Primary outcome
2-year recurrence-free survival rate
Time frame: 2 years
percentage of recurrence-free survival 2 years after surgery
1 secondary outcome
Correlation between ctDNA-MRD status dynamic changes and relapse
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mingxin Pan principal investigator
Southern Medical University, China
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma Resectable, run by Zhujiang Hospital at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mingxin Pan, Prof. (+8618928918216, pmxwxy@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year recurrence-free survival rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.