Comparing radiation therapy with and without chemoembolization for large liver tumors
Comparison of Efficacy in Stereotactic Body Radiation Therapy (SBRT) of Large Hepatocellular Carcinoma (5-10 cm) With or Without Transcatheter Arterial Chemoembolization (TACE)
This study is testing whether adding a special type of chemotherapy to radiation therapy helps people with large liver tumors live longer and have fewer side effects.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 30 Years to 80 Years |
| Sex | All |
| Sponsor | Beijing 302 Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Beijing) |
| Trial ID | NCT04512846 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness and side effects of stereotactic body radiation therapy (SBRT) in patients with large hepatocellular carcinoma (HCC) measuring 5-10 cm, with some receiving additional transcatheter arterial chemoembolization (TACE). The goal is to optimize treatment schedules by evaluating overall survival rates, progression-free survival rates, local control, and the occurrence of adverse reactions in both treatment groups. Participants will be closely monitored to assess the outcomes of these combined therapies.
Who should consider this trial
Good fit: Ideal candidates are patients with a single large HCC lesion (5-10 cm) who are not suitable for other therapies and have a good performance status.
Not a fit: Patients with tumor thrombus, lymph node involvement, or extrahepatic metastasis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes and survival rates for patients with large HCC.
How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * primary HCC diagnosed by a surgeon and/or radiologist and oncologist according to the international guidelines for the management of HCC or by pathology * single lesion and longest tumor diameter were 5-10cm; * CP-A or B classification; * Eastern Cooperative Oncology Group (ECOG) score 0-1; * distances between tumor and normal organs (esophagus, stomach, duodenum, bowel) are more than 5 mm * unsuitable for other therapies, such as patients with heart disease, uncontrolled diabetes, uncontrolled hypertension, etc. * rejecting other therapies such as resection, liver transplantation, etc. * platelet count≥50 × 109/L, white blood count≥1.5 × 109/L; * patients infected with hepatitis B virus who are treated with adefovir or entecavir; patients infected with hepatitis C virus whose HCV DNA are negative. Exclusion Criteria: * tumor thrombus; * lymph node involvement; * extrahepatic metastasis.
Where this trial is running
Beijing
- Beijing 302 hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Jing Sun
- Email: 519299998@qq.com
- Phone: +8613718681094
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.