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Value of Dynamic Monitoring of Early Recurrence of Hepatocellular Carcinoma After Radical Resection Based on CTCS

ConditionsHepatocellular CarcinomaCirculating Tumor CellRecurrenceSurgery
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorZhujiang Hospital

About this trial

On the basis of previous retrospective studies, the Task Force will further optimize the CTCs longitudinal surveillance model and initially validate the subclonal origin (CTC-DNA) of recurrent/metastatic foci derived from CTCs at the molecular level in hepatocellular carcinoma, prospective clinical trials will be conducted to further validate the predictive value of the CTCS longitudinal monitoring model in predicting postoperative recurrence of hepatocellular carcinoma, and to verify whether it is earlier than imaging to indicate recurrence, to explore the clinical feasibility of CTCs in guiding postoperative adjuvant therapy of liver cancer, and to provide new ideas for early intervention strategy of liver cancer after operation, to establish a set of standardized clinical scheme of auxiliary treatment for patients with liver cancer after operation for accurate and individualized"Early diagnosis and treatment".

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

Patient can't provide blood samples for CTCs and CTC-DNA testing;

Patient with two or more types of tumors at the same time;

Non-primary liver lesions;

Pregnant or lactating women;

Trial population

Patient with hepatocellular carcinoma who can undergo radical surgical resection

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • circulating tumor cells

    Diagnostic test

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

Treatment groups

82 Participants
are divided into 1 treatment group
Group A: Patient with hepatocellular carcinoma1 intervention

Trial outcomes

Primary outcomes

1

2-year recurrence-free survival rate

percentage of recurrence-free survival 2 years after surgery

Time frame
2 years

Secondary outcomes

1

Correlation between CTCs status dynamic changes and relapse

Correlation between CTCs status dynamic changes and relapse

Time frame
2 years
2

Correlation between metastasis，primary tumor and CTCs in blood through NGS and CTC-DNA

The subclonal origin of recurrent/metastatic foci derived from CTCs was verified at the molecular level in hepatocellular carcinoma

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhujiang Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: