Hepatocellular carcinoma
Conditions
Interventions
experimental group:Iodine-125 seeds strand+TACE+Sorafenib
control group:TACE+Sorafenib
Sponsors
Zhongshan Hospital affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with unresectable hepatocellular carcinoma diagnosed clinically or pathologically; 2. Patients with BCLC stage C (type VP3 of portal vein tumor thrombus); 3. Patients with child Pugh score a / b (= 18 years and <= 75 years old is more than 3 months; 6. Patients and / or family members agree to join the clinical trial and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Diffuse liver cancer or tumor is not suitable for mrecist evaluation in patients with tumor load greater than or equal to 70%; 2. Patients with VP1, VP2 and VP4 types of portal vein tumor thrombus; 3. Patients who have previously received treatment for liver cancer or portal vein tumor thrombus (including external radiotherapy, local ablation, Tai / TACE, iodine 125 seed implantation, systemic chemotherapy, targeted therapy, immunotherapy, etc.); 4. Patients with hepatic vein or inferior vena cava tumor thrombus; 5. Patients with lymph node metastasis and extrahepatic distant metastasis; 6. Patients with malignant tumors of other sites confirmed; 7. The liver function was classified as child Pugh C, which could not be improved by liver protection treatment; 8. Patients with refractory massive ascites; 9. Patients with active infection, especially inflammation of bile duct system; 10. Patients with peripheral blood leucopenia and thrombocytopenia, severe coagulation dysfunction and uncorrectable: leucocyte 2.3 or prothrombin time (PT) exceeding the upper limit of normal for 3 seconds; 11. Patients with renal dysfunction: creatinine (CR)> 176.8 µ mol/L(2 mg/dl) or creatinine clearance rate (CCR) < 30 ml/min, with serious heart, lung, and brain diseases; 12. Female patients are pregnant or lactating; 13. Patients and / or their family members did not agree to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median Survival Time (OS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Time To Progression (TTP); | — |
Countries
China
Contacts
Public ContactZihan Zhang
Zhongshan Hospital affiliated to Fudan University
Outcome results
None listed