Clinical trial · Interventional
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
NCT06766643CI-TRIAL-00084523recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A phase II clinical trial of stereotactic radiosurgery versus radiofrequency ablation in the treatment of inoperable primary liver cancer in specific sites
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Liver Cancer | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiofrequency ablation therapy | Procedure | — | UNRESOLVED |
| Stereotactic Body Radiation Therapy (SBRT) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Stereotactic body radiation therapy group
- interventionNames
- Procedure: Stereotactic Body Radiation Therapy (SBRT)
- type
- EXPERIMENTAL
- label
- Radiofrequency ablation therapy group
- interventionNames
- Procedure: Radiofrequency ablation therapy
Primary outcomes (1)
- measure
- PFS
- timeFrame
- Until the end of the study, about 2 years
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.