Hepatocellular carcinoma
Conditions
Interventions
Experimental group:TAI (Precise medication)
Control group:Regular TACE
Sponsors
The Fifth Medical Center of PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria, aged 18 to 75 years, both male and female; 2. Patients with high risk factors for recurrence after liver resection; Including but not limited to tumor diameter> 5 cm, vascular invasion, no tumor envelope, alpha-fetoprotein (AFP)> 32ng/mL, liver cirrhosis, HBV-DNA level> 103IU/ml, tumor envelope invasion or deletion, multiple Patients with sexual tumor nodules or satellite foci, preoperative tumor rupture, lymph node metastasis, poor tumor cell differentiation, and other patients with tumor recurrence after other treatments; 3. Child-Pugh Class A/B (= 50%, renal function Cr = 1.5 x 10^9/ L, HGB>=90 g/L, PLT>=60x10^9 pieces/L; 6. The patient can tolerate surgical treatment in general, and there is no obvious heart, lung, liver, and kidney dysfunction; 7. With the consent of the ethics committee, the patient and his family members are aware of and informed; 8. Sign the consent form before treatment.
Exclusion criteria
Exclusion criteria: 1. Participate in other clinical trials/drug trials within 3 months before enrollment; 2. Severe jaundice, moderate and large amounts of ascites; 3. Extremely bad general condition or cachexia; 4. Child-Pugh Grade C for severe liver insufficiency; 5. Severe multiple organ dysfunction; 6. Active infection, especially co-infection; 7. Female patients during pregnancy or lactation; 8. If the patient is receiving any drug treatment that may cause QTc prolongation, the disease People must stop their drug treatment 7 days before receiving TATE or TACE treatment; 9. The patient has prolonged QTc history due to any reason, or before TATE/TACE treatment The QTc interval of ECG examination is >480 ms (QTcF); 10. There is any active autoimmune disease or a history of autoimmune disease; 11. Before entering the study, the following conditions occurred: myocardial infarction, severe/unstable angina, NYHA level 2 or higher cardiac insufficiency, poorly controlled arrhythmia (including QTcF interval> 450 ms for males,> 470 ms for females, QTcF Interval is calculated by Fridericia formula), symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism); 12. Known history of psychotropic drug abuse or drug abuse; 13. Patients who meet the contraindications in the instructions of each chemotherapeutic drug; 14. There are other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the research, or interfere with the results of the research, and patients who the researcher thinks are not suitable for participating in the research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival rate;untreatable tumor progression;Progression Free Survival;Safety; | — |
Countries
China
Contacts
Public ContactXie Hui
The Fifth Medical Center of PLA General Hospital
Outcome results
None listed