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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06449846
• Other study ID #: 2024-KY-094-02
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Zhujiang Hospital
• Contact: Mingxin Pan, Prof.
• Phone: +8618928918216
• Email: pmxwxy[@]sohu.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 152
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma Resectable
• Recurrence
• Surgery

Intervention

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

Locations

Country	Name	City	State
China	Shunde Hospital of Southern Medical University	Foshan	Guangdong
China	The Sixth Affiliated Hospital of South China University of Technology	Foshan	Guangdong
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guanzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	1-year recurrence-free survival rate	percentage of recurrence-free survival 1 years after surgery	1 years
Primary	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	2-year recurrence-free survival rate	percentage of recurrence-free survival 2 years after surgery	2 years