Stereotactic Radiosurgery Versus Radiofrequency Ablation for Primary Liver Cancer
Recruiting
Phase 2Interventional Study
Primary Liver Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
130 (estimated)
Sponsor
Tianjin Medical University Cancer Institute and Hospital · Other
Who this trial is looking for
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Answer a few quick questions to see if you may meet the eligibility requirements.
A phase II clinical trial of stereotactic radiosurgery versus radiofrequency ablation in the treatment of inoperable primary liver cancer in specific sites
Trial Locations
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Status
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…
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.
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