Circulating Tumor Cell, Hepatocellular Carcinoma, Recurrence, Surgery
Conditions
Keywords
Hepatocellular Carcinoma, Circulating Tumor Cell, Recurrence, Dynamic Monitoring
Brief summary
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 individualizedEarly diagnosis and treatment.
Detailed description
The recurrence rate of HCC after radical resection is high. MRD is the root cause of HCC recurrence, and the MRD result is an important basis for auxiliary treatment decision-making after radical resection. 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 individualizedEarly diagnosis and treatment, to provide high-quality evidence-based medicine for the clinical practice of preventing recurrence after radical hepatectomy
Interventions
DIAGNOSTIC_TESTcirculating tumor cells
blood sample and tissue specimen for circulating tumor cell and DNA will be done to patient with hepatocellular carcinoma
Sponsors
Zhujiang Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 CTCs and CTC-DNA 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-year recurrence-free survival rate | 2 years | percentage of recurrence-free survival 2 years after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between CTCs status dynamic changes and relapse | 2 years | Correlation between CTCs status dynamic changes and relapse |
| Correlation between metastasis，primary tumor and CTCs in blood through NGS and CTC-DNA | 2 years | The subclonal origin of recurrent/metastatic foci derived from CTCs was verified at the molecular level in hepatocellular carcinoma |
Countries
China
Contacts
Primary ContactMingxin Pan, Prof.
Backup ContactZhoubin Feng
Outcome results
None listed