Stereotactic Radiosurgery Versus Radiofrequency Ablation for Primary Liver Cancer
Recruiting now · Phase 2
Conditions studied: Primary Liver Cancer
In brief
A phase II clinical trial of stereotactic radiosurgery versus radiofrequency ablation in the treatment of inoperable primary liver cancer in specific sites
Key facts
- Study ID
- NCT06766643
- Run by
- Tianjin Medical University Cancer Institute and Hospital
- People needed
- 130
- Starts
- 2025-01-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-01-09
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- 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 (enrolling)
Full record on ClinicalTrials.gov
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