Clinical trial NCT06449846: Compare the Accuracy of ctDNA-MRD and MVI Result in Predicting Postoperative Recurrence of Hepatocellular Carcinoma
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hepatocellular Carcinoma Resectable
Surgery
Recurrence
Keywords: Hepatocellular Carcinoma
Circulating Tumor DNA
Minimal Residual Disease
Microvascular Invasion
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with hepatocellular carcinoma who can undergo radical surgical resection

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 2 years
Secondary outcomes:
measure: 2-year recurrence-free survival rate
timeFrame: 2 years
Other outcomes:
measure: 1-year recurrence-free survival rate
timeFrame: 1 years
Locations:
city: Foshan
country: China
facility: Shunde Hospital of Southern Medical University
state: Guangdong
city: Foshan
country: China
facility: The Sixth Affiliated Hospital of South China University of Technology
state: Guangdong
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
city: Guanzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Southern Medical University
name: Mingxin Pan, Prof.
role: PRINCIPAL_INVESTIGATOR
References: