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NCT Number: NCT06317896

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

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".

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Sixth Affiliated Hospital of South China University of Technology, Foshan, Guangdong, China

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

circulating tumor cells

Diagnostic Test

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

Other names: circulating tumor cell DNA

Primary outcomes

  1. 2-year recurrence-free survival rate

    Time frame: 2 years

    percentage of recurrence-free survival 2 years after surgery

Secondary outcomes

  1. Correlation between CTCs status dynamic changes and relapse

    Time frame: 2 years

    Correlation between CTCs status dynamic changes and relapse

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

    Time frame: 2 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Mingxin Pan, Prof.

CONTACT

[email protected]

+8618928918216

Zhoubin Feng

CONTACT

[email protected]

19830551997

Sponsors and collaborators

Lead sponsor

Zhujiang Hospital

Other

Registry information

Official study title

Value of Dynamic Monitoring of Early Recurrence of Hepatocellular Carcinoma After Radical Resection Based on CTCS: a Prospective Cohort Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2024
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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