Liver cancer
Conditions
Interventions
Experimental Group:Ethanol chemical dissolution agent doped with gelatin-iodine contrast medium and other drugs
Control group:Traditional ethanol chemical dissolution agent
Sponsors
Dazhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) Patients of any gender, aged 18-60 years, with a life expectancy of >=3 months; (2) Patients with primary hepatocellular carcinoma confirmed by histology or cytology, or meeting the clinical diagnostic criteria of the ‘Guidelines for the Diagnosis and Treatment of Primary Liver Cancer’ (2022 edition) issued by the National Health Commission (chronic liver disease, typical imaging features, AFP changes); (3) BCLC stage A; (4) Single lesion or no more than 3 lesions in the liver; (5) At least one lobe of the portal vein is unobstructed; (6) Patients with liver function of Child-A grade before surgery or Child-B grade who can reach Child-A grade after liver protection, nutrition and fluid therapy; (7) Eastern Cooperative Oncology Group status score (ECOG PS) = white blood cell count >=3.0×10^9/L; 350×10^9/L>= platelet count >=50×10^9/L; prothrombin time (PT) does not exceed the upper limit of normal control by 3 seconds; serum creatinine is less than 1.5 times the upper limit of normal; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are both less than 3 times the upper limit of normal; (9) The patient is informed in detail of the possible advantages and disadvantages before and after the operation, and the patient and his family members voluntarily choose the treatment plan and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients who have received treatment for liver cancer or portal vein cancer thrombus in the past (including: surgery, external radiotherapy, molecular targeted drugs, local ablation, TAI/TAE/TACE, etc.) (2) Patients with cancer thrombus extending into the superior mesenteric vein and/or splenic vein; and patients with combined hepatic vein, inferior vena cava cancer thrombus or extrahepatic metastasis; (3) Patients with confirmed malignant tumors in other parts of the body; (4) Patients with serious diseases of important organs such as the heart, lung, kidney, and brain; (5) Patients with contraindications to radiofrequency ablation: patients with ethanol allergy, coagulation disorders, and a large amount of ascites in the abdominal cavity; patients with total bilirubin > 51umol/L and/or albumin <28g/L who have not improved after symptomatic treatment; patients with active infection, especially inflammation of the bile duct system; female patients who are pregnant or lactating (6) Patients and/or their families do not agree to join the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response,OR;Disease control,DC;PFS,progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver function;Blood routine; | — |
Countries
China
Contacts
Public ContactJie Liu
Dazhou Central Hospital
Outcome results
None listed