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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06317896
• Other study ID #: 2024-KY-048-01
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2024
• Source: Zhujiang Hospital
• Contact: Mingxin Pan, Prof.
• Phone: +8618928918216
• Email: pmxwxy[@]sohu.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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".

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 82
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Circulating Tumor Cell
• Hepatocellular Carcinoma
• Neoplastic Cells, Circulating
• Recurrence
• Surgery

Intervention

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

Locations

Country	Name	City	State
China	The Sixth Affiliated Hospital of South China University of Technology	Foshan	Guangdong
China	Affiliated Cancer Hospital and Institute of Guangzhou Medical University	Guangzhou	Guangdong
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year recurrence-free survival rate	percentage of recurrence-free survival 2 years after surgery	2 years
Secondary	Correlation between CTCs status dynamic changes and relapse	Correlation between CTCs status dynamic changes and relapse	2 years
Secondary	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	2 years