Advanced unresectable hepatocellular carcinoma
Conditions
Interventions
Study group:Ultra-stable homogeneous lipiodol-chemotherapy drugs & ICG preparations
Control group: traditional interventional surgery
Sponsors
Affiliated Hospital of Southwest Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) The patient is not limited to gender, aged 18-60 years, and life expectancy = 3 months; (2) The cause confirmed by histology or cytology, or in line with the clinical diagnostic criteria (basis of chronic liver disease, typical imaging features, AFP changes) issued by the National Health Commission of the People's Republic of China in the "Code for Diagnosis and Treatment of Primary Liver Cancer" (2022 Edition) patients with hepatocellular carcinoma; (3) The stage of BCLC is B or C (surgical resection is not suitable or the damage of surgical resection is large, liver transplantation, local ablation therapy); (4) The single or multiple lesions in the liver are located in the hemi-liver or limited to three adjacent liver lobes; (5) The primary branch of the portal vein in at least one leaf is unobstructed; (6) Those whose liver function was Child-A before surgical resection or whose liver function was Child-B could reach Child-A after treatment such as liver protection and nutritional supplementation; (7) Eastern Cooperative Oncology Group status score (ECOG PS) = 2; (8) Reach the following indicators after treatment and correction: 9.5×109/L=white blood cell count=3.0×109/L; 350×109/L=platelet count=50×109/L; prothrombin time (PT) does not exceed The upper limit of the normal control is 3 seconds; serum creatinine is less than 1.5 times the upper limit of the normal; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are both less than 3 times the upper limit of the normal; (9) Inform the patient of the possible advantages and disadvantages before and after the operation in detail, and the patient and his family members voluntarily choose the treatment plan and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients with recurrent liver cancer or those who have previously received treatment for liver cancer or portal vein tumor thrombus (including: surgery, external radiotherapy, molecular targeted drugs, local ablation, TAI/TAE/TACE, etc.) (2) The tumor thrombus extends into the superior mesenteric vein and (or) splenic vein; and those with hepatic vein, hepatic segmental inferior vena cava tumor thrombus or extrahepatic metastasis; (3) Combined with diagnosed malignant tumors in other parts; (4) Severe heart, lung, kidney, brain and other vital organ diseases; (5) Contraindications for combined TACE: diffuse liver cancer or tumor volume accounting for 70% or more of the whole liver, refractory massive ascites, high-flow intrahepatic arteriovenous shunt; total bilirubin > 51umol/L and (or) albumin <28g/L, who failed to improve after symptomatic treatment; combined with active infection, especially inflammation of the bile duct system; female patients who are pregnant or breastfeeding (6) Patients who are allergic to lipiodol or iodine; (7) The patient and/or family members do not agree to join the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response;disease control;Complete remission, CR;Partial remission, PR;Stable disease,SD;Progression-free survival;Overall survival,OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory tests (blood routine, liver and kidney function, cardiac function);Alpha fetoprotein, AFP;Surgical resection effect (operation time, blood loss, blood transfusion rate, R0 margin rate);Surgical resection effect (operation time, blood loss, blood transfusion rate, R0 margin rate); | — |
Countries
China
Contacts
Public ContactLi Bo
Affiliated Hospital of Southwest Medical University
Outcome results
None listed