hepatocellular carcinoma
Conditions
Interventions
Sponsors
Zhongshan Hospital affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Clinical or pathological diagnosed HCC; 2. Inoperable BCLC B stage ; 3. No vascular invasion, no lymph nodes and distant metastasis; 4. ECOG score 0-1; 5. Child-Pugh A ; 6. Receive no previous cancer directed therapy 7. Have at least one target lesion within RECIST 1.1 version; 8. expected life expancy more than 12 weeks; 9. Aged at least 18 years gender unlimited 10. In Chronic HBV patients, HBV-DNA quantification should be less than 500 IU/mL; HBsAg patients should receive antiviral therapy; HCV patients (HCV-RNA positive)should receive antiviral therapy and liver function within grade CTCAE 1; 11. Women of childbearing age and men must agree to adopt birth control measures from the time of signing the informed consent form; 12 Patients should have preserved bone marrow and liver renal function as follow: (1) Hemoglobin >= 90 g/L (2) Neutrophil count >= 1.5*10^9/L (3) Platelet count >= 75*10^9/L (4) Total bilirubin = 29 g/L (6) serum ALT /AST 50 mL/min (9) urine protein = ++24 hour protein quantification < 1.0).
Exclusion criteria
Exclusion criteria: 1. Cholangiocarcinoma or Cholangiocarcinoma-hepatocellular carcinoma or complicated with other malignancy within past 5 years; 2. Uncontrolled infection; 3. history of allergy to drugs; 4. HIV infection; 5. Pregnancy or lactation; 6. Having severe bleeding symptoms or confirmed gastrointestinal bleeding tendency In the past 30 days, (patients with occult blood in stool++ and above are not allowed to enter the group); 7. Suffering from myocardial ischemia of grade II or above or infarction or poorly controlled arrhythmia (QTc interval >= 450 ms for male and >= 470 ms for female); 8. Left ventricular ejection fraction = 500 IU/ml; Hepatitis C: HCV-RNA is positive and liver function is obviously abnormal; Co-infection of hepatitis B and hepatitis C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficiency of tumour stiffness in predicting TACE efficacy; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;Comparison of the efficacy between tumor stiffness and HAP score;comparison of the efficacy between tumor stiffness and STATE score; | — |
Countries
China
Contacts
Public ContactRongxin Chen
Zhongshan Hospital affiliated to Fudan University
Outcome results
None listed