Hepatocellular Carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with TACE insufficiency of inoperable HCC (BCLC stage B and stage C) confirmed by imaging or histology; 2. Aged >=18 years male and female; 3. Child Pugh 5-6 grade A; 4. ECoG score 0-2; 5. The life expectancy exceeds 3 months; 6. Bone marrow function: neutrophil >=1.5x10^9/L, platelet >=75x10^9/L, hemoglobin >=90g/L; 7. Liver and kidney function: serum creatinine <=1.5 ULN; AST and alt <=5 ULN; total bilirubin <=1.5 ULN; 8. BCLC patients in stage B were treated with TACE for 1-2 times at first, once a month. After the last TACE for 1 month, enhanced CT was used to evaluate the insufficient lipiodol deposition and residual enhanced tumor focus; 9. BCLC stage C patients can be enrolled in the group 2 weeks after TACE treatment; 10. Patients have good compliance with the planned treatment, can understand the research process of this study and sign the written informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women, as well as childbearing age patients who refuse to take appropriate contraceptive measures during the trial; 2. Patients with sufficient lipiodol deposition and complete remission after TACE treatment; 3. Exclusion of contraindications to antiangiogenic drugs: 1) Those who have high blood pressure and cannot be controlled by antihypertensive drugs; 2) Urine routine showed positive protein = + +; 3) There are many factors that affect oral medicine (inability to swallow, chronic diarrhea, intestinal obstruction, etc.); 4) Abnormal coagulation and bleeding tendency: for example, active ulcer, occult blood in stool (+ +); 5) Grade 3-4 cardiac insufficiency (NYHA standard); 6) Severe hepatorenal insufficiency (grade 4). 4. Having untreated central nervous system disease or symptomatic central nervous system metastasis disease; 5. According to the judgment of researchers, there are serious concomitant diseases endangering the safety of patients or affecting the completion of the study; 6. The estimated survival time is less than 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to progress; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression free survival; | — |
Countries
China
Contacts
SanXia Hospital Affiliated to Chongqing University