Prediction of Hepatocellular Carcinoma Recurrence After Curative Treatment by Longitudinal Monitoring MRD Based on ctDNA
- Conditions
- Hepatocellular Carcinoma Resectable
- Interventions
- Diagnostic Test: circulating tumor DNA
- Registration Number
- NCT06157060
- Lead Sponsor
- Zhujiang Hospital
- Brief 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 255
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patient with hepatocellular carcinoma circulating tumor DNA Patient with hepatocellular carcinoma who can undergo radical resection
- Primary Outcome Measures
Name Time Method 2-year recurrence-free survival rate 2 years percentage of recurrence-free survival 2 years after surgery
- Secondary Outcome Measures
Name Time Method Correlation between ctDNA-MRD status dynamic changes and relapse 2 years Correlation between ctDNA-MRD status dynamic changes and relapse
Trial Locations
- Locations (7)
Zhujiang Hospital of Southern Medical University
π¨π³Guangzhou, Guangdong, China
The Sixth Affiliated Hospital of South China University of Technology
π¨π³Foshan, Guangdong, China
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
π¨π³Guangzhou, Guangdong, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
π¨π³Guangzhou, Guangdong, China
Shunde Hospital of Southern Medical University
π¨π³Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
π¨π³Guangzhou, Guangdong, China
Yuebei People's Hospital
π¨π³Shaoguan, Guangdong, China