Primary liver cancer or metastatic liver cancer
Conditions
Interventions
Experimental group:Receive HKSFU therapy
Sponsors
Shu lan(Bo Ao) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18–75 years (inclusive of 18 and 75 years), any gender; 2. Patients with a clear diagnosis of primary liver cancer or metastatic liver cancer, meeting any one of the following four diagnostic criteria can be enrolled: (1) According to the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2019 Edition)", those diagnosed with primary liver cancer by histopathology or clinical diagnosis; (2) Patients with a clear pathological diagnosis of intrahepatic cholangiocarcinoma or mixed cell carcinoma; (3) Patients with liver lesions accompanied by hepatitis, AFP > 400 µg/L; or AFP > 200 µg/L for more than 2 months; (4) Patients with liver metastases clearly diagnosed by imaging or pathology, who after systemic treatment have no extrahepatic lesions, or extrahepatic lesions are stable or disappeared, and meet the conditions for local liver treatment; 3. Single tumor with a maximum diameter <= 5 cm; or tumor number <= 3 with maximum diameter <= 3 cm; 4. Liver function grade Child-Pugh A or B, or achieves this standard after medical treatment; 5. Tumor clearly visible on ultrasound; 6. Tumor depth from body surface <= 13 cm; 7. ECOG-PS score <= 1; 8. Expected survival period exceeding three months; 9. Patient voluntarily signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. The treatment-related area has skin ulceration or infection; 2. The treatment-related area has previously undergone radiotherapy or local ultrasound ablation; 3. Significant calcification exists in the arterial vessel wall in the ultrasound treatment path; 4. Failure of important organ functions; 5. Severe coagulation dysfunction or patients with a clear tendency to bleed; 6. Interventional or surgical treatment within one month before surgery; 7. Accompanied by tumor thrombus in vessels or invasion of adjacent organs; 8. Liver function is Child-Pugh class C and cannot be improved with liver-protective treatment; 9. Esophageal (gastric fundus) variceal rupture bleeding within 1 month before treatment; 10. Refractory massive ascites, cachexia; 11. Patients have an active infection, especially biliary system inflammation; 12. Human immunodeficiency virus (HIV) positive; 13. Severe brain disease, diffuse liver cancer, or other mental disorders; 14. Pregnant or breastfeeding women; 15. Patients who have participated in other clinical trials targeting local lesions within 3 months before enrollment, or participated in other device clinical trials within 1 month before enrollment; 16. Other conditions deemed unsuitable for enrollment by the investigator;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate 3 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| ECOG-PS score;AFP value and Child-Pugh classification of liver function;The complete ablation rates of tumor lesions at 1 month, 3 months, and 6 months after surgery;Average change in tumor volume;Evaluation of equipment performance; | — |
Countries
China
Contacts
Public ContactWu Zhang
Shu lan(Bo Ao) Hospital
Outcome results
None listed