Compare the Accuracy of ctDNA-MRD and MVI Result in Predicting Postoperative Recurrence of Hepatocellular Carcinoma

Compare the Accuracy of Circulating Tumor DNA Longitudinal Monitoring Minimal Residual Disease and Microvascular Invasion Result in Predicting Postoperative Recurrence of Hepatocellular Carcinoma

The aim of this study was to compare the accuracy of ctDNA-MRD longitudinal surveillance model and internationally accepted pathological MVI results in predicting recurrence after radical hepatectomy. At the same time, to explore the relationship among the two methods of predicting recurrence of hepatocellular carcinoma, postoperative adjuvant therapy and postoperative recurrence, this study further confirmed the effectiveness of ctDNA-MRD longitudinal monitoring model in monitoring postoperative recurrence of hepatocellular carcinoma and guiding treatment.

Study Overview

• Status: Not yet recruiting
• Conditions: Recurrence; Surgery; Hepatocellular Carcinoma Resectable
• Intervention / Treatment: Diagnostic test: circulating tumor cell DNA detection

Detailed Description

The recurrence rate of hepatocellular carcinoma (HCC) after radical hepatectomy is high, and there is no universally accepted adjuvant therapy to prevent recurrence of liver cancer at present.The high-risk recurrent population can not be accurately and dynamically located. The results showed that minimal residual disease (MRD) was the root of recurrence of HCC, and the results of MRD were the important indicator of adjuvant therapy. Our previous research confirmed that the circulating tumor DNA (ctDNA)-MRD monitoring model can accurately predict the recurrence of HCC, which provides important evidence for the application of MRD in predicting the recurrence of early HCC. It was also found in the retrospective analysis that the patients with ctDNA positive after radical hepatectomy were treated with targeted therapy and other comprehensive therapies, while ctDNA converting to negative, the tumor-free survival was significantly prolonged.

Microvascular invasion (MVI) is a pathological concept, which refers to the nests of cancer cells in the lumen of small blood vessels under the microscope, the results of MVI can be obtained by pathological examination of the tumor tissue after hepatectomy. MVI is common in HCC and is associated with early recurrence and decreased survival. MVI is an important determinant of survival after radical hepatectomy, the grade (severity) of MVI is generally associated with tumor stage and the rate of liver cancer disease progression, which has been widely studied and recognized internationally.

The aim of this study was to compare the accuracy of ctDNA-MRD longitudinal surveillance model and internationally accepted pathological MVI results in predicting recurrence after radical hepatectomy. At the same time, to explore the relationship among the two methods of predicting recurrence of hepatocellular carcinoma, postoperative adjuvant therapy and postoperative recurrence, this study further confirmed the effectiveness of ctDNA-MRD longitudinal monitoring model in monitoring postoperative recurrence of hepatocellular carcinoma and guiding treatment.

• Study Type: Observational
• Enrollment (Estimated): 152

Contacts and Locations

• Study Contact: Name: Mingxin Pan, Prof.; Phone Number: +8618928918216; Email: pmxwxy@sohu.com
• Study Contact Backup: Name: Jianan Feng; Phone Number: 13825522877; Email: 972929217@qq.com

Study Locations

• China
  • Guangdong
    • Foshan, Guangdong, China
      • Shunde Hospital of Southern Medical University
      • Contact: Weidong Wang, Prof.; Phone Number: 13702835586
      • Principal Investigator: Weidong Wang, Prof.
    • Foshan, Guangdong, China
      • The Sixth Affiliated Hospital of South China University of Technology
    • Guangzhou, Guangdong, China, 510220
      • Zhujiang Hospital of Southern Medical University
      • Contact: Mingxin Pan, Prof.; Phone Number: +8618928918216; Email: pmxwxy@sohu.com
      • Principal Investigator: Mingxin Pan, Prof.
      • Contact: Jianan Feng; Phone Number: 13825522877; Email: 972929217@qq.com
    • Guanzhou, Guangdong, China
      • Sun Yat-sen University Cancer Center

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient with hepatocellular carcinoma; Patient with hepatocellular carcinoma who can undergo radical resection	Diagnostic test: circulating tumor cell DNA detection; 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
The ROC curve of two methods are obtained according to the results of recurrence prediction 2 years after hepatectomy，and the primary outcome measure is the area under the ROC curve (AUC value) for two methods	The receiver operating characteristic curve (ROC) is made according to the recurrence of the patients after operation, and the accuracy of ctDNA-MRD longitudinal monitoring model and pathological MVI results are judged by comparing the area under the ROC curve (AUC value)	2 years

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-year recurrence-free survival rate	percentage of recurrence-free survival 1 years after surgery	1 years

Collaborators and Investigators

• Sponsor: Zhujiang Hospital
• Investigators: Principal Investigator: Mingxin Pan, Prof., Southern Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 30, 2024
• First Submitted That Met QC Criteria: June 3, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Actual): June 10, 2024
• Last Update Submitted That Met QC Criteria: June 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Hepatocellular Carcinoma; Circulating Tumor DNA; Minimal Residual Disease; Microvascular Invasion
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Disease Attributes; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Recurrence
• Other Study ID Numbers: 2024-KY-094-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No