Liver cancer
Conditions
Sponsors
Shanghai Sixth People’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Patients aged between 18 and 75 years old (inclusive of 18 and 75), regardless of gender; 2) Patients with a clear diagnosis of primary liver cancer or metastatic liver cancer who meet any of the following four diagnostic criteria can be included: ?Please refer to the "Diagnosis and Treatment Guidelines for Primary Liver Cancer (2019 Edition)," diagnosed as primary liver cancer by histopathology or clinical diagnosis; ?Pathologically diagnosed liver bile duct cell carcinoma or mixed cell carcinoma; ?Patients with liver masses accompanied by hepatitis, AFP > 400µg/L; or AFP > 200µg/L persisting for more than 2 months; ? diagnosed with liver metastatic tumors by imaging or pathology, and after systematic treatment, there are no lesions outside the liver, or lesions outside the liver are stable or disappeared, meeting the conditions for local liver treatment; 3) Single tumor, maximum diameter = 5cm; or = 3 tumors, maximum diameter = 3cm each; 4) Liver function grade Child-Pugh A or B, or meets this standard after internal medicine treatment; 5) Clear visibility of the tumor on B-ultrasound; 6) Tumor depth from the body surface = 13cm; 7) ECOG-PS score = 1; 8) Expected survival period of more than three months; 9) Patients voluntarily signing an informed consent form.
Exclusion criteria
Exclusion criteria: 1) There is skin ulceration or infection in the relevant area treated; 2) Those who have received radiotherapy and local ultrasound ablation in the relevant areas of treatment; 3) There is significant calcification of the arterial vessel wall in the ultrasound treatment channel; 4) Failure of important organs; 5) Patients with severe coagulation dysfunction or clear bleeding tendency; 6) Those who use interventional treatment or surgical treatment within one month before surgical treatment; 7) Those accompanied by vascular tumor thrombus or invasion of adjacent organs; 8) Liver function Child-Pugh C grade, which cannot be improved by liver-protective treatment; 9) Those who have experienced esophageal (gastric fundus) variceal bleeding within 1 month before treatment; 10) Stubborn large amounts of abdominal effusion and cachexia; 11) The patient has active infection, especially inflammation of the biliary system; 12) Human immunodeficiency virus (HIV) positive persons; 13) Those with severe brain disease or diffuse liver cancer or other mental illness; 14) Pregnant or lactating women; 15) The patients have participated in other clinical trials for the treatment of local lesions 3 months before enrollment, or participated in other device clinical trials within 1 month before enrollment; 16) Other situations judged by the researcher to be unsuitable for enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate at 3 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| The complete ablation rate of tumor lesions at 1 month, 3 months, and 6 months after surgery;Mean tumor volume changes at 1 month, 3 months, and 6 months after surgery;AFP values and Child Push liver function grading at 1 month, 3 months, and 6 months after surgery;ECOG-PS scores at 1 month, 3 months, and 6 months after surgery;Equipment performance evaluation; | — |
Countries
China
Contacts
Public ContactYing Tao
Shanghai Sixth People’s Hospital
Outcome results
None listed