Using CyberKnife radiation therapy for small liver tumors in patients with severe liver disease
CyberKnife Stereotactic Body Radiation Therapy for Small Hepatocellular Carcinoma
This study is testing if CyberKnife radiation therapy can safely help people with small liver tumors and severe liver disease who can't have other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 30 Years to 80 Years |
| Sex | All |
| Sponsor | Beijing 302 Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Beijing) |
| Trial ID | NCT04512833 on ClinicalTrials.gov |
What this trial studies
This research evaluates the effectiveness and safety of CyberKnife stereotactic body radiation therapy in patients with small hepatocellular carcinoma (HCC) who also have decompensated cirrhosis. The study focuses on patients who are not candidates for other treatments and have specific health criteria, such as adequate liver volume and no portal vein tumor thrombus. By utilizing advanced radiation technology, the aim is to provide a targeted treatment option for this challenging patient population.
Who should consider this trial
Good fit: Ideal candidates include patients with small hepatocellular carcinoma and decompensated cirrhosis who are not suitable for other treatment options.
Not a fit: Patients with tumor thrombus, extrahepatic metastasis, or lymph node involvement will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with small HCC and decompensated cirrhosis, potentially improving their survival and quality of life.
How similar studies have performed: While there have been studies on CyberKnife for HCC, this specific approach in patients with decompensated cirrhosis is relatively novel and less explored.
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 * Unfeasible or refusing to undergo other treatments; * Residual normal liver volume ≥700 cc; * With decompensated cirrhosis (Child-Pugh B or C classification); * Without portal vein tumor thrombus; * Eastern Cooperative Oncology Group (ECOG) score 0-1; * Distances between tumor and normal organs (esophagus, stomach, duodenum, bowel) are more than 5 mm； * 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: * With Tumor thrombus； * With extrahepatic metastasis; * With lymph node involvement.
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.