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Starting soon Observational

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

NCT06317896 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2024-04-01
Last updated
2024-03-19

Condition(s) studied

Hepatocellular CarcinomaCirculating Tumor CellRecurrenceSurgery

Investigational drug(s) / intervention(s)

circulating tumor cells

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

Study 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 individualized"Early diagnosis and treatment".

Eligibility

Sex
ALL
Min age
18 Years
Max age
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.

Primary outcome measure(s)

  • 2-year recurrence-free survival rate — 2 years
    percentage of recurrence-free survival 2 years after surgery

Trial sites (3)

FacilityCityRegionStatus
The Sixth Affiliated Hospital of South China University of Technology Foshan Guangdong
Zhujiang Hospital of Southern Medical University Guangzhou Guangdong
Affiliated Cancer Hospital and Institute of Guangzhou Medical University Guangzhou Guangdong
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06317896 on ClinicalTrials.gov ↗ ← All trials in China