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
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".
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Zhujiang Hospital |
China,
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 |
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