Comparing SBRT and Ablation for Liver Cancer Treatment
Stereotactic Body Radiotherapy Versus Ablation for Perivascular Hepatocellular Carcinoma: A Phase 2, Multicenter, Randomized Controlled Trial
NA · Sun Yat-sen University · NCT04434989
This study is testing whether Stereotactic Body Radiation Therapy (SBRT) works better than radiofrequency ablation (RFA) for treating liver cancer in patients with perivascular hepatocellular carcinoma.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University (other) |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04434989 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness and safety of Stereotactic Body Radiation Therapy (SBRT) compared to radiofrequency ablation (RFA) for treating perivascular hepatocellular carcinoma. It is a multi-center, phase III, randomized trial aiming to enroll 170 patients diagnosed with this type of liver cancer. Participants will be randomly assigned to receive either SBRT or RFA, and the primary outcomes will focus on the local recurrence rate and disease-free survival after one year.
Who should consider this trial
Good fit: Ideal candidates include patients with unifocal hepatocellular carcinoma tumors ≤5cm that are close to major blood vessels and have a good performance status.
Not a fit: Patients with vascular invasion, extra-hepatic metastasis, or significant liver dysfunction are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with perivascular hepatocellular carcinoma.
How similar studies have performed: Previous studies have shown promising results for both SBRT and RFA in treating liver tumors, indicating that this approach is built on established methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Primary hepatocellular carcinoma or recurrent hepatocellular carcinoma after curative treatment. 2. Unifocal tumor ≤5cm 3. Closed to great vessels (diameter ≥3mm) 4. ECOG score 0-1 5. Child-Pugh grade A or B7 6. Sufficient liver and kidney function Exclusion Criteria: 1. Vascular invasion 2. Extra-hepatic metastasis 3. Received TACE before 4. Inflammation of local skin 5. Dysfunction of liver, kidney or bone marrow. 6. Concomitant other malignant tumor or HIV infection
Where this trial is running
Guangzhou, Guangdong
- The First Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hepatocellular Carcinoma