NCT06766643 Stereotactic Radiosurgery Versus Radiofrequency Ablation for Primary Liver Cancer
| NCT ID | NCT06766643 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital |
| Condition | Primary Liver Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2025-01 |
| Primary Completion | 2025-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 130 participants in total. It began in 2025-01 with a primary completion date of 2025-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A phase II clinical trial of stereotactic radiosurgery versus radiofrequency ablation in the treatment of inoperable primary liver cancer in specific sites
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06766643 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Primary Liver Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06766643 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06766643 currently recruiting?
Yes, NCT06766643 is actively recruiting participants. Contact the research team at tjchi@hotmail.com for enrollment information.
Where is the NCT06766643 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06766643 clinical trial?
NCT06766643 is sponsored by Tianjin Medical University Cancer Institute and Hospital. The trial plans to enroll 130 participants.
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