Terminal-stage or unresectable hepatocellular carcinoma
Conditions
Interventions
Control Group:TACE and common lipiodol embolization was used during the operation
Experimental Group :TACE and super-liquid lipiodol embolization was used during the operation
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years old; 2. Single or 2-3 tumor diameter is larger than 5cm, non diffuse liver cancer; patients cannot accept palliative surgery or radiotherapy, or can only request TACE treatment; BCLC stage: B-C; 3. All segments of hepatic arteries can be displayed on the CBCT angiography image of the common hepatic artery; 4. CBCT scanning images showed no obvious interference of respiratory motion artifact; 5. In strict accordance with the "primary liver cancer diagnosis standard" (2011 Edition) diagnostic criteria or by histology or cytology of recurrence / metastasis of unresectable HCC patients, and can not accept palliative surgery or radiotherapy, and at least one measurable disease (according to the requirements of the 1.1 edition of RECIST measurable disease spiral CT scan length 10mm or lymph node enlargement short diameter is greater than or equal to 15mm); 6. Child-Pugh liver function rating: a grade B or better (=7); 7. The ECOG PS score was 0-1 points within 1 weeks before admission; 8. The expected survival time over 12 weeks; 9. HBV DNA < 2000 IU/ml (104 copy /ml); 10. The main organs function normally, that is, the following standards: (1): blood routine examination of HB = 90 g/L; ANC = 1.5 * 10^9/L; PLT = 60 * 10^9/L; (2) biochemical examination: ALB = 29 g/L; ALT and AST<2.5 (ULN; TBIL = 2 (ULN = 1.5 (ULN; creatinine; 11. women of childbearing age should have a pregnancy test within 7 days before entering the group; 12. subjects voluntarily joined the study, signed informed consent, good compliance, and followed up.
Exclusion criteria
Exclusion criteria: Patients who meet the following 1 or more items are not eligible for this study: 1. Within the 4 weeks prior to the study, any local treatment except for TACE (including surgery, radiation, hepatic artery embolization, hepatic arterial infusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) was received; 2. Diffuse liver cancer; known hepatocholangiocarcinoma and mixed cell carcinoma and fibrolamellar carcinoma; previous (within 5 years) or with other untreated malignant tumors, except for healed skin basal cell carcinoma and cervical carcinoma in situ; 3. Patients undergoing liver transplantation (except those who had undergone liver transplantation); 4. Ascites with clinical symptoms requires therapeutic peritoneal puncture or drainage, or Child-Pugh score > 2; 5. People with hypertension who are unable to fall within normal range by antihypertensive medications (systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg); 6. With the grade of myocardial ischemia or myocardial infarction, poor control of the arrhythmia (including QTc interval = 450 male MS, female = 470 MS); 7. LVEF (left ventricular ejection fraction) was less than 50% according to the NYHA standard, grade III to IV, cardiac dysfunction, or echocardiography; 8. There are a variety of factors that affect oral medications (such as inability to swallow, chronic diarrhea and intestinal obstruction, which significantly affect the use and absorption of drugs); 9. In the past 6 months with the history of alimentary tract hemorrhage or definite gastrointestinal bleeding tendency, such as: the risk of esophageal variceal bleeding, local active ulcerative lesions, fecal occult blood (+ +) = not into the group; such as fecal occult blood (+), requirements for gastroscopy; 10. abdominal fistula, gastrointestinal perforation, or abdominal abscess occurred within 28 days before the study; 11. abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4 seconds), with bleeding tendency or undergoing thrombolysis or anticoagulant therapy; 12. patients with central nervous system metastasis or known brain metastases have been reported; 13. previous and present pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug related objective evidence of pneumonia, lung dysfunction, etc.; 14. urine routine showed that urinary protein is more than + + or confirm the urine protein in 24 hours, 1 g; 15. pregnant or lactating women; fertile patients who are unwilling or unable to adopt effective contraception; 16. there is a history of mental illness or psychotropic substance abuse; 17. patients with bone metastases had received palliative radiotherapy within 4 weeks prior to the study Treatment area > 5% bone marrow area; 18. joint HIV infected patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AFP;Overall Survival OS;Disease Control Rate,DCR;Time To Progress, TTP; | — |
Countries
China
Contacts
Public ContactXinwei Han
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed