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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

152 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatocellular Carcinoma Resectable Surgery Recurrence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient with hepatocellular carcinoma

Patient with hepatocellular carcinoma who can undergo radical resection

circulating tumor cell DNA detection

Intervention Type DIAGNOSTIC_TEST

circulating tumor DNA blood sample and tissue specimen for circulating tumor DNA will be done to patient with hepatocellular carcinoma

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No