Prediction of Hepatocellular Carcinoma Recurrence After Curative Treatment by Longitudinal Monitoring MRD Based on ctDNA

Hepatocellular Carcinoma Resectable Clinical Trial

Official title:

Prediction of Hepatocellular Carcinoma Recurrence After Curative Treatment by Longitudinal Monitoring Minimal Residual Disease Based on Circulating Tumor DNA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06157060
• Other study ID #: 2023-KY-232-01
• Status: Recruiting
• Start date: November 20, 2023
• Est. completion date: December 30, 2026

Study information

• Verified date: November 2023
• Source: Zhujiang Hospital
• Contact: Mingxin Pan, Prof.
• Phone: +8618928918216
• Email: pmxwxy[@]sohu.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will conduct a prospective cohort study to verify the predictive value of ctDNA-MRD longitudinal monitoring model in predicting postoperative recurrence, verify whether ctDNA-MRD longitudinal monitoring model can indicate recurrence earlier than imaging examination, and explore the feasibility of guiding adjuvant therapy after curative treatment based on this model.

Description:

The recurrence rate of hepatocellular carcinoma after curative treatment is high, and the minimal residual disease(MRD) in patients is the major cause of liver cancer recurrence, and the MRD is an important basis for the decision of adjuvant therapy after curative treatment. Previous studies have confirmed that circulating tumor DNA(ctDNA)-MRD monitoring model can accurately predict the recurrence of hepatocellular carcinoma patients. It was also found in retrospective analysis that tumor free survival was significantly prolonged after ctDNA-positive treatment for hepatocellular carcinoma after resection. This study will conduct a prospective cohort study to verify the predictive value of ctDNA-MRD longitudinal monitoring model in predicting postoperative recurrence, verify whether ctDNA-MRD longitudinal monitoring model can indicate recurrence earlier than imaging examination, and explore the feasibility of guiding adjuvant therapy after curative treatment based on this model.This study is to verify the predictive value of ctDNA-MRD longitudinal monitoring model in predicting postoperative recurrence.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 255
• Est. completion date: December 30, 2026
• Est. primary completion date: November 20, 2023
• 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 ctDNA 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
• Hepatocellular Carcinoma Resectable
• Recurrence

Intervention

Diagnostic Test:
• circulating tumor DNA
blood sample and tissue specimen for circulating tumor 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	Guangdong Provincial Hospital of Traditional Chinese Medicine	Guangzhou	Guangdong
China	Shunde Hospital of Southern Medical University	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong
China	Yuebei People's Hospital	Shaoguan	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 ctDNA-MRD status dynamic changes and relapse	Correlation between ctDNA-MRD status dynamic changes and relapse	2 years