Hepatecellular carcinoma
Conditions
Interventions
the treatment arm:patinib combined with TACE
the control group:TACE with Radiotherapy
Sponsors
Affiliated Tumor Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Adult patients aged between 18 and 80 years old; 2. Patients with clinical or histological diagnosis of HCC based on Chinese guideline of diagnosis and treatment for primary liver cancer; 3. Child-pugh class A or B(Child-puh score 7); 4. Patients with stage C HCC according to Barcelona Clinic Liver Cancer staging criteria with invasion in portal vein(PVTT I-II or <50% III); 5. Unable to radical excision; 6. Confined to half-liver; 7. Did not accept any antitumor comprehensive treatment; 8. ECOG performance status of 0 or 1; 9. Life expectancy of at least 3 months; 10. Adequate bone marrow,liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening: (1) Blood routine inspection: HGB=90 g/L; absolute neutrophil count(ANC)=1.5×10^9/L; platelet count=60×10^9/L; (2) Biochemical examination: ALB =29 g/L; ALTAST<2.5 ULN; TBIL =2 ULN; Cr =1.5 ULN; Albumin and bilirubin indicators can only one has been evaluated to two points in Child-Pugh class 11. Patients must provide signed written informed consent.
Exclusion criteria
Exclusion criteria: 1.Pregnant, lactating, or have fertility women, who unwilling or unable to take effective contraceptive measures and the pregnancy test positive should be excluded. 2.Patients have received radiotherapy or chemotherapy within 2 months before the study; 3.In the past (within 5 years) or at the same time,patients were diagnosed with other malignant tumor which have not been cured. 4.Patients with clinical symptoms of ascites, equal to need therapeutic abdominal puncture or drainage 5.Patients who are diagnosed with hypertension which cant be reduced to normal range via antihypertensive drug treatment(systolic blood pressure> 140 mmHg / diastolic blood pressure> 90 mmHg); 6.Patients who are diagnosed with II or higher level of myocardial ischemia, myocardial infarction, uncontrolled arrhythmia(including QTc interval prolongation men> 450 ms, female> 470 ms); 7.Exist the Grade ?? Cardiac insufficiency according to NYHA standard or LVEF(Left ventricular ejection fraction)1.5 or PT> ULN+4s), and the patients are able to be faced with a bleeding tendency or being treated with thrombolysis and anticoagulation; 13.Urine routine inspection suggests that the urine protein =++;24 hours urine protein examination>1.0 g; 14.With a mental illness, or has a history of psychiatric drugs abuse; 15.patients with HIV infection. 16. Possible factors may affect the clinical research, which judged by the researchers, should be excluded to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TTP;OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;PFS;Surgical conversion rate;life quality score; | — |
Countries
China
Contacts
Public ContactGong Wenfeng
Affiliated Tumor Hospital of Guangxi Medical University
Outcome results
None listed