Actively Recruiting
Study Comparing Stereotactic Body Radiation Therapy and Radiofrequency Ablation in Inoperable Primary Liver Cancer A Randomized Controlled Phase II Trial for Tumors Near Critical Liver Areas
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 important structures like major blood vessels, the diaphragm, liver capsule, or porta hepatis. This Phase II clinical trial compares the safety and effectiveness of stereotactic radiotherapy and radiofrequency ablation in this specific patient group. Patients are carefully selected based on surgical evaluation and diagnosis confirmed by imaging or biopsy. Participants will be randomly assigned to one of two groups: stereotactic body radiation therapy (SBRT), which delivers a total radiation dose of 40 to 50 Gy over 3 to 5 sessions, or radiofrequency ablation therapy, which involves a complete ablation of the liver lesions. The study plans to enroll approximately 65 patients in each treatment arm. Throughout the study, which lasts about two years, patients will be closely monitored for progression-free survival. Researchers will conduct imaging tests and assessments to track treatment response and side effects. The study includes careful evaluation of liver function, overall health status, and survival prognosis to ensure patient safety and gather comprehensive data about these treatments.
CONDITIONS
Official 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 study procedures
- Age between 18 and 75 years
- Child-Pugh score 7 or less and Karnofsky Performance Status 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 hepatocellular carcinoma or recurrence within 2 years after radical treatment
- At least one measurable lesion by imaging, lesion size no larger than 5 cm, and total lesions no more than 3
- No previous anti-tumor treatment
- Sufficient normal liver volume
- Normal major organ functions including blood counts, liver tests, and kidney function within specified limits
- Stable breathing for more than 10 minutes
- Expected survival time greater than 2 years
You will not qualify if you...
- Potential for surgical intervention
- Serious uncontrolled cardiovascular, pulmonary, or other organ diseases causing poor health
- Severe liver dysfunction beyond trial criteria
- Other cancers diagnosed within 5 years before or at hepatocellular carcinoma diagnosis
- Significant bleeding symptoms or bleeding tendency within 3 months before enrollment
- Participation in other interventional clinical trials or investigational treatments within 4 weeks before first treatment
- Previous treatment with anti-target tumor therapies
- History of upper abdominal radiotherapy
- Uncontrolled active comorbidities
- Poor prognosis or inability to provide informed consent
AI-Screening
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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
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