๐ฌIn plain words
What the trial is, and whether it could suit you
A phase II clinical trial of stereotactic radiosurgery versus radiofrequency ablation in the treatment of inoperable primary liver cancer in specific sites
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
1. Prior to implementing any trial-related procedures, written informed consent must be signed;
2. Age โฅ 18 years and โค 75 years;
3. Child-Pugh score โค 7;KPS score โฅ 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 โค 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 \[absolute neutrophil count (ANC) โฅ 1.5 ร 10\^9, platelets โฅ 70 ร 10\^9, hemoglobin โฅ 80 g/L\], liver function tests \[bilirubin \< 3.0 mg/dL, international normalized ratio (INR) \< 1.7, albumin โฅ 2.8 g/dL, aspartate transaminase (AST)/alanine transaminase (ALT) \< 6\], serum creatinine \< 1.5 times the upper limit of normal, or creatinine clearance โฅ 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.