Monitoring blood for early signs of liver cancer recurrence after treatment

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

This study is testing if monitoring blood for cancer DNA can help find out sooner if liver cancer comes back after treatment, so doctors can better manage care for patients.

Quick facts

• Study type: Observational
• Enrollment: 255 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Zhujiang Hospital (Academic / other)
• Locations: 7 sites (Foshan, Guangdong and 6 other locations)
• Trial ID: NCT06157060 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effectiveness of a circulating tumor DNA (ctDNA) monitoring model in predicting the recurrence of hepatocellular carcinoma after curative treatment. It will assess whether this model can detect recurrence earlier than traditional imaging methods and explore its potential to guide adjuvant therapy. The study will involve a prospective cohort of patients who have undergone surgery for liver cancer, with a focus on analyzing their ctDNA levels over time. By establishing the predictive value of ctDNA-MRD monitoring, the study seeks to improve postoperative management of liver cancer patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with resectable hepatocellular carcinoma who have not received prior anti-tumor therapy.

Not a fit: Patients with multiple tumors, non-primary liver lesions, or serious comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to earlier detection of liver cancer recurrence and more effective treatment strategies for patients.

How similar studies have performed: Previous studies have shown promising results with ctDNA monitoring in predicting cancer recurrence, indicating that this approach is supported by existing research.

Eligibility criteria

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.

Where this trial is running

Foshan, Guangdong and 6 other locations

• The Sixth Affiliated Hospital of South China University of Technology — Foshan, Guangdong, China (Recruiting)
• Zhujiang Hospital of Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
• Affiliated Cancer Hospital and Institute of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
• Guangdong Provincial Hospital of Traditional Chinese Medicine — Guangzhou, Guangdong, China (Recruiting)
• Shunde Hospital of Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
• Yuebei People's Hospital — Shaoguan, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Mingxin Pan — Southern Medical University
• Study coordinator: Mingxin Pan, Prof.

Conditions Hepatocellular Carcinoma Resectable