Value of Dynamic Monitoring of Early Recurrence of Hepatocellular Carcinoma After Radical Resection Based on CTCS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: circulating tumor cells.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma, Circulating Tumor Cell, Recurrence, Surgery. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Value of Dynamic Monitoring of Early Recurrence of Hepatocellular Carcinoma After Radical Resection Based on CTCS: a Prospective Cohort Study
Overview
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".
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 individualized"Early diagnosis and treatment", to provide high-quality evidence-based medicine for the clinical practice of preventing recurrence after radical hepatectomy
Interventions
- Diagnostic test circulating tumor cells
blood sample and tissue specimen for circulating tumor cell and DNA will be done to patient with hepatocellular carcinoma
Primary outcome measures
- 2-year recurrence-free survival rate [Time frame: 2 years]
Secondary outcome measures (2)
- Correlation between CTCs status dynamic changes and relapse [Time frame: 2 years]
- Correlation between metastasis，primary tumor and CTCs in blood through NGS and CTC-DNA [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- 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);
- Not received any anti-tumor therapy;
- Laboratory tests were at normal levels within 7 days before enrollment.
Exclusion criteria
- 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;
- 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;
- Patient with serious heart disease;
- Other conditions deemed unsuitable for inclusion by the researcher.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 3 centers
- The Sixth Affiliated Hospital of South China University of Technology — Foshan
- Zhujiang Hospital of Southern Medical University — Guangzhou
- Affiliated Cancer Hospital and Institute of Guangzhou Medical University — Guangzhou
Identifiers
NCT: NCT06317896 · 2024-KY-048-01