Actively Recruiting
A Prospective, Randomized, Controlled Phase II Clinical Trial of Stereotactic Radiosurgery Versus Radiofrequency Ablation in Primary Liver Cancer in a Special Site of Surgical Evaluation for Non-operable
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2025-01-09
130
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatment options for patients with primary liver cancer who cannot undergo surgery due to tumor location near critical areas like major blood vessels, the diaphragm, liver capsule, or liver hilum. This phase II clinical trial compares the safety and effectiveness of stereotactic radiosurgery and radiofrequency ablation in these patients. The study aims to determine which treatment is preferred for tumors in these challenging locations. Participants will be randomly assigned to one of two treatment groups: one receiving stereotactic body radiation therapy (SBRT) with a total dose of 40 to 50 Gy delivered over 3 to 5 sessions, and the other receiving a single complete radiofrequency ablation procedure targeting the liver lesions. The study plans to enroll 65 patients in each group, with treatments delivered based on investigator assessment and randomization. During the study, participants will undergo regular imaging and clinical evaluations to measure progression-free survival, overall survival rates, and control rates of the tumor both locally and in other parts of the liver or body. These assessments will continue for about two years. The research team will monitor liver function, organ health, and respiratory stability, ensuring patient safety and treatment adherence throughout the trial period.
CONDITIONS
Brief Title
Stereotactic Radiosurgery Versus Radiofrequency Ablation for Primary Liver Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before trial procedures
- Age between 18 and 75 years
- Child-Pugh score of 7 or less and Karnofsky Performance Score of 70 or higher
- Confirmed diagnosis of hepatocellular carcinoma by imaging or biopsy
- Tumor located near major blood vessels, diaphragm, liver capsule, or liver hilum
- Assessed as inoperable or recurrence within 2 years after radical treatment
- At least one measurable lesion by imaging, lesion size not exceeding 5 cm, and total lesions 3 or fewer
- No previous anti-tumor treatment
- Sufficient normal liver volume aside from tumors
- Normal major organ functions meeting specified blood and liver test criteria
- Stable respiration for more than 10 minutes
- Expected survival time greater than 2 years
You will not qualify if you...
- Potential for surgical intervention
- Serious comorbidities such as uncontrolled cardiovascular, pulmonary, or other organ dysfunctions
- Severe liver dysfunction beyond trial criteria
- Other malignancies within 5 years prior to or at diagnosis
- Significant bleeding or bleeding tendency within 3 months prior to enrollment
- Participation in other interventional trials or investigational treatments within 4 weeks
- Previous anti-target tumor therapies
- History of upper abdominal radiotherapy
- Uncontrolled active comorbidities
- Not meeting expected survival prognosis or unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 to 5 fractions for stereotactic body radiation therapy or 1 session for radiofrequency ablation therapy
Participants receive either stereotactic body radiation therapy or radiofrequency ablation therapy as treatment for their primary liver cancer.
3 to 5 visits for stereotactic body radiation therapy or 1 visit for radiofrequency ablation therapy
Duration - Up to 2 years
Participants are monitored for progression-free survival and other outcomes, including overall survival and local control rates, for up to about 2 years after treatment.
Regular follow-up visits as scheduled by the study team
Trial Site Locations
Total: 1 location
1
Department of Hepatobiliary Oncology and Radiation Oncology,Tianjin Medical University Cancer Institute & Hospital,Key Laboratory of Cancer Prevention and Therapy,National Clinical Research Center for Cancer, Tianjin's Clinical Research Center for Cancer
Tianjin, China, 300060
Actively Recruiting
Research Team
S
Song Tianqiang T Song, MD
M
Meng Maobin M Meng, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here