hepatocellular carcinoma
Conditions
Interventions
the treatment arm:apatinib combined with TACE
the control arm:cTACE
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
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. Patients with at least one bi-dimensionally measurable lesion by multiphasic spiral CT scan or dynamic contrast enhanced MRI; 4. Patients must not be a candidate for surgical resection or ablation of the tumour =10cm in largest dimension; 5. Patients with stage B or C HCC according to Barcelona Clinic Liver Cancer staging criteria without invasion in main portal vein or extrahepatic metastasis; 6. Prior TACE treatment times no more than 3; 7. Child-pugh class A or B(Child-puh score 7); 8. ECOG performance status of 0 or 1; 9. Life expectancy of at least 12 weeks; 10. Adequate bone marrow,liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening: Hb=90g/L; absolute neutrophil count>1000/mm3; WBC=2x10^9/L; platelet count=50x10^9/L; adequate clotting function: INR=1.5 or PT>ULN+4s; hepatic: ALB=29g/L, ALT or AST 1000/mm3; WBC=2x10^9/L; platelet count=50x10^9/L; adequate clotting function: INR=1.5 or PT>ULN+4s; hepatic: ALB=29g/L, ALT or AST <5xULN; renal:serum creatinine =1.5xULN; TBIL=1.5xULN. 11. Patients must provide signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who are on a liver transplant list; 2. Presence of invasion in main portal vein or extrahepatic metastasis; 3. Pregnant or lactating women; 4. Patients has received prior TACE treatment more than 3 times; 5. Hypertension defined as systolic blood pressure>160mmHg or diastolic pressure>100mmHg despite optimal medical management; 6. Impairment of swallowing that would preclude administration of apatinib; 7. Associated with CNS(central nervous system) metastasis,with psychotropic drug abuse history and can't get rid of or mental disorder patients; 8. Abnormal coagulation (INR>1.5 APTT>1.5xULN), with bleeding tendency; 9. Patients with high gastrointestinal bleeding risk,including the following conditions:local active ulcer lesions with positive fecal occult blood test(++),history of black stool,or vomiting blood in the past 6 months; 10. Urinary protein result exceeds ++ or 24h urinary protein content>1.0g; 11. Coronary heart disease greater than chass II level arrhythmia(including QT interval prolongation ,for man=450ms,for woman=470ms)together with class I cardiac dysfunction; 12. Previous treatment with VEGFR inhibitor(i.e. apatinib,sorafenib,sunitinib).;Exclusion criteria: 1. Patients who are on a liver transplant list; 2. Presence of invasion in main portal vein or extrahepatic metastasis; 3. Pregnant or lactating women; 4. Patients has received prior TACE treatment more than 3 times; 5. Hypertension defined as systolic blood pressure>160mmHg or diastolic pressure>100mmHg despite optimal medical management; 6. Impairment of swallowing that would preclude administration of apatinib; 7. Associated with CNS(central nervous system) metastasis,with psychotropic drug abuse history and can't get rid of or mental disorder patients; 8. Abnormal coagulation (INR>1.5 APTT>1.5xULN), with bleeding tendency; 9. Patients with high gastrointestinal bleeding risk,including the following conditions:local active ulcer lesions with positive fecal occult blood test(++),history of black stool,or vomiting blood in the past 6 months; 10. Urinary protein result exceeds ++ or 24h urinary protein content>1.0g; 11. Coronary heart disease greater than chass II level arrhythmia(including QT interval prolongation ,for man=450ms,for woman=470ms)together with class I cardiac dysfunction; 12. Previous treatment with VEGFR inhibitor(i.e. apatinib,sorafenib,sunitinib).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TTP;;TTP; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;PFS;DCR;ORR;;OS;PFS;DCR;ORR; | — |
Countries
China
Contacts
Public ContactYinghua Zou;Yinghua Zou ;
Peking University First Hospital;Peking University First Hospital
Outcome results
None listed