Hepatocelullar Carcinoma
Conditions
Interventions
Experimental arm:Intercalated combination of TACE and palliative radiotherapy
Sponsors
Guiping People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily joined the study and signed informed consent; 2. Male and femle age 18-75 years old patients with hepatocellular carcinoma and the expected survival = 12 weeks; 3. Clinically or pathologically newly diagnosed hepatocellular carcinoma accompanied by multiple(>3 lesions)or massive lesions(=10cm)that are inappropriate resection,SBRT,radiofrequency or microwave ablation. The diameter of the lesion should =1.0cm or the enlarged lymph node of 1.5cm according to RECIST v1.1; 4. Liver function Child-Pugh score = 8 points; 5. ECOG performance status Grade 2 or less; 6. The functions of vital organs meet the following requirements(No blood components, cytokines, or other corrective therapy should be used within 14 days before the first administration): Hemoglobin=90 g/L; neutrophil count=1.5*10^9/L; platelet count=60*10^9/L; serum albumin=30g/l; Total bilirubin=1.5*ULN; ALT and AST=3*ULN; AKP=2.5*ULN; Creatinine=1.5*ULN; 7. HBV-DNA1000 copies/ml, oral antiviral drugs should be recommended at least 1 week before TACE; 8. For non-surgical sterilization or reproductive age of female patients, a medically approved method of contraception is required during the study and within 3 months after treatment.
Exclusion criteria
Exclusion criteria: 1. Patients who had received radiotherapy, TACE, and radiofrequency or microwave ablation; 2. Patients with distant extensive metastases; 3. The portal vein is completely embolized and the collateral vessels are less formed; 4. Patients with diffuse liver cancer; 5. Ascites with clinical symptoms requiring puncture, continuous drainage, or receiving ascites drainage for the past 3 months, except for those who showed a small amount of ascites by imaging,but without linicalptoms; 6. Have heart clinical symptoms or disease that are not well controlled:(1) heart failure above grade 2, unstable angina pectoris; (2) myocardial infarction occurred within 1 year; (3) supraventricular or ventricular arrhythmia needs treatment or intervention; 7. Bleeding symptoms with significant clinical significance or a clear tendency to bleeding were observed within 3 months; 8. Known hereditary or acquired bleeding and tendency to thrombosis such as hemophilia patients, coagulopathy, thrombocytopenia and so on; 9. Patients with active infection; 10. Patients with HIV, HCV or syphilis; 11. The patient had other malignant tumors within the previous 3 years or at the same time; 12. Other reasons were not considered appropriate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress free survival(PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression (TTP);Over-all survival (OS);overall response rate (ORR);Adverse events(AE); | — |
Countries
China
Contacts
Public ContactXu Yaocan
Guiping People's Hospital
Outcome results
None listed