Intermediate to advanced hepatocellular carcinoma
Conditions
Interventions
experimental group:Preoperative iodide - indocyanine green emulsion embolization downstaging treatment + surgical treatment
control group:Conventional TAE+ surgical treatment
Sponsors
Affiliated Zhongshan Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. The patients are not limited in gender, 18-60 years old, and their life expectancy is more than 3 months; 2. Patients with primary hepatocellular carcinoma confirmed by histology or cytology, or meet the clinical diagnostic criteria (chronic liver disease basis, typical imaging features, AFP changes) of "diagnosis and treatment of primary liver cancer" (2019 Edition) issued by the health commission; 3. Patients with BCLC stage B or C (not suitable for surgical resection or surgical resection with severe injury, liver transplantation and local ablation); 4. Patients with single or multiple intrahepatic lesions located in half liver or limited to three adjacent hepatic lobes; 5. Patients with unobstructed primary branch of portal vein at least one leaf; 6. The patients whose liver function was child-a or child-b before operation, and could reach child-a after liver protection, nutrition and rehydration; 7. Patients with ECoG PS = white blood cell count >= 3.0 * 10^9 / L; 350 * 10^9 / L >= platelet count >= 50 * 10^9 / L; prothrombin time (PT) did not exceed the upper limit of normal control for 3 seconds; serum creatinine was less than 1.5 times of normal upper limit; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were less than 3 times of normal upper limit; 9. Inform the patients of the advantages and disadvantages that may occur before and after the operation, and the patients and their families choose the treatment plan voluntarily and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with recurrent liver cancer or previously treated with liver cancer or portal vein tumor thrombus (including surgery, external radiotherapy, molecular targeted drugs, local ablation, Tai / TACE, etc.) 2. Patients with tumor thrombus extending into superior mesenteric vein and / or splenic vein, and those with hepatic vein, inferior vena cava tumor thrombus or extrahepatic metastasis; 3. Patients with other malignant tumors confirmed; 4. Patients with serious heart, lung, kidney, brain and other important organ diseases; 5. Patients with TACE contraindications: diffuse liver cancer or tumor volume accounting for 70% or more of the whole liver, intractable large amount of ascites, intrahepatic high flow arteriovenous shunt; patients with total bilirubin > 51umol / L and / or albumin < 28g / L, which can not be improved after symptomatic treatment; patients with active infection, especially inflammation of biliary system; female patients in pregnancy or lactation period; 5.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| operation time;The bleeding;Blood transfusion rate;Rate of R0 cut edge;Hepatic portal block time;progression-free survival;Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative ALT and AST levels;Hospital stays;Hospital costs;Time To Progression TTP;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactLi Bo
Affiliated Hospital, Southwest Medical University
Outcome results
None listed