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

Not yet recruiting

• Conditions: Hepatocellular Carcinoma; Circulating Tumor Cell; Surgery; Recurrence
• Interventions: Diagnostic Test: circulating tumor cells

• Registration Number: NCT06317896
• Lead Sponsor: Zhujiang Hospital

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 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

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-12
• Study First Submitted QC: 2024-03-12
• Last Update Submitted: 2024-03-12
• Study First Posted: 2024-03-19
• Last Update Posted: 2024-03-19
• Study Start: 2024-04-01
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 82

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with hepatocellular carcinoma	circulating tumor cells	Patient with hepatocellular carcinoma who can undergo radical resection

Primary Outcome Measures

Name	Time	Method
2-year recurrence-free survival rate	2 years	percentage of recurrence-free survival 2 years after surgery

Secondary Outcome Measures

Name	Time	Method
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
Correlation between CTCs status dynamic changes and relapse	2 years	Correlation between CTCs status dynamic changes and relapse

Trial Locations

Locations (3)

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

Zhujiang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

Affiliated Cancer Hospital and Institute of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China