Stereotactic Radiosurgery Versus Radiofrequency Ablation for Primary Liver Cancer
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
Tianjin Medical University Cancer Institute and Hospital
130 participants
Jan 1, 2025
INTERVENTIONAL
Conditions
Summary
A phase II clinical trial of stereotactic radiosurgery versus radiofrequency ablation in the treatment of inoperable primary liver cancer in specific sites
Eligibility
Inclusion Criteria12
- Prior to implementing any trial-related procedures, written informed consent must be signed;
- Age ≥ 18 years and ≤ 75 years;
- Child-Pugh score ≤ 7;KPS score ≥ 70;
- The patient must be clearly diagnosed with hepatocellular carcinoma, usually confirmed through imaging (CT, MRI) or histological examination (biopsy);
- The tumor is located near major blood vessels/diaphragm/liver capsule/liver hilum;
- Surgically assessed as inoperable hepatocellular carcinoma or recurrence of primary hepatocellular carcinoma within 2 years after radical treatment;
- According to the criteria for evaluating the efficacy of solid tumors, there should be at least one measurable lesion by imaging, with the lesion size not exceeding 5 cm; total number of lesions ≤ 3;
- No previous anti-tumor treatment;
- Normal liver (liver volume minus tumor volume) is sufficient;
- Normal major organ functions, including blood routine tests \[absolute neutrophil count (ANC) ≥ 1.5 × 10\^9, platelets ≥ 70 × 10\^9, hemoglobin ≥ 80 g/L\], liver function tests \[bilirubin < 3.0 mg/dL, international normalized ratio (INR) < 1.7, albumin ≥ 2.8 g/dL, aspartate transaminase (AST)/alanine transaminase (ALT) < 6\], serum creatinine < 1.5 times the upper limit of normal, or creatinine clearance ≥ 60 mL/min;
- Stable respiration for more than 10 minutes;
- Expected survival time > 2 years.
Exclusion Criteria10
- Possible surgical intervention;
- Presence of other serious comorbidities, such as uncontrolled cardiovascular diseases, pulmonary diseases, or dysfunction of other organs, where the overall health status is poor and may result in treatment intolerance;
- Severe liver dysfunction exceeding the specific criteria defined in the trial;
- Other malignancies diagnosed within 5 years prior to the first treatment or at the time of diagnosis of hepatocellular carcinoma;
- Significant clinically meaningful bleeding symptoms or a clear bleeding tendency within 3 months prior to enrollment;
- Currently participating in an interventional clinical trial treatment, or having received other investigational drugs or used investigational devices within 4 weeks before the first treatment;
- Previous treatment with anti-target tumor therapies;
- History of upper abdominal radiotherapy;
- Uncontrolled active comorbidities;
- Not meeting the expected survival prognosis or unable to provide informed consent.
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Interventions
Stereotactic radiosurgery for liver lesions: with a total dose of 40\~50Gy/3\~5fraction;
Radiofrequency ablation therapy:1 complete radiofrequency ablation of liver lesions for liver lesions
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06766643