Stereotactic Radiosurgery Versus Radiofrequency Ablation for Primary Liver Cancer

Launched by TIANJIN MEDICAL UNIVERSITY CANCER INSTITUTE AND HOSPITAL · Jan 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different treatments for primary liver cancer that cannot be surgically removed: stereotactic radiosurgery and radiofrequency ablation. Stereotactic radiosurgery uses targeted radiation to destroy cancer cells, while radiofrequency ablation uses heat to do the same. The goal is to see which treatment works better for patients with tumors that are close to major blood vessels or other sensitive areas in the liver.

To participate in this trial, individuals must be between 18 and 75 years old and have a confirmed diagnosis of liver cancer. They should also have good overall health and specific liver function scores. Participants will need to sign a consent form to join and can expect to receive one of the two treatments while being monitored for their health and response to therapy. It's important to note that individuals with certain health conditions or previous treatments may not be eligible to join the study.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Prior to implementing any trial-related procedures, written informed consent must be signed;
• • 2. Age ≥ 18 years and ≤ 75 years;
• • 3. Child-Pugh score ≤ 7;KPS score ≥ 70;
• • 4. The patient must be clearly diagnosed with hepatocellular carcinoma, usually confirmed through imaging (CT, MRI) or histological examination (biopsy);
• • 5. The tumor is located near major blood vessels/diaphragm/liver capsule/liver hilum;
• • 6. Surgically assessed as inoperable hepatocellular carcinoma or recurrence of primary hepatocellular carcinoma within 2 years after radical treatment;
• • 7. 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;
• • 8. No previous anti-tumor treatment;
• • 9. Normal liver (liver volume minus tumor volume) is sufficient;
• • 10. 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;
• • 11. Stable respiration for more than 10 minutes;
• • 12. Expected survival time \> 2 years.
• Exclusion Criteria:
• • 1. Possible surgical intervention;
• • 2. 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;
• • 3. Severe liver dysfunction exceeding the specific criteria defined in the trial;
• • 4. Other malignancies diagnosed within 5 years prior to the first treatment or at the time of diagnosis of hepatocellular carcinoma;
• • 5. Significant clinically meaningful bleeding symptoms or a clear bleeding tendency within 3 months prior to enrollment;
• • 6. 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;
• • 7. Previous treatment with anti-target tumor therapies;
• • 8. History of upper abdominal radiotherapy;
• • 9. Uncontrolled active comorbidities;
• • 10. Not meeting the expected survival prognosis or unable to provide informed consent.