hepatocellular carcinoma
Conditions
Interventions
Case series:Apatinib+TILA-TACE
Sponsors
The Second Affiliated hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged at least 18 years; 2. Patients with unresectable hepatocellular carcinoma (HCC) strictly conform to the clinical diagnostic criteria of the Standards for the Diagnosis and Treatment of Primary Hepatocellular Carcinoma (2017 edition) or Histologically or cytologically confirmed diagnosis of unresectable hepatocellular carcinoma (HCC) and having at least one measurable lesion; 3. Patients with measurable lung metastases, excluding primary lung cancer; 4. Child-pugh liver function Rating: A level, B level (= score 7); 5. BCLC Staging as B/ C period; 6. No tumor thrombus in portal vein trunk; 7. ECOG(Eastern Cooperative Oncology Group) :0~1; 8. The Expected lifetime:= 12 weeks; 9. Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function ). For example: HB=90 g/L, ANC>1.5×10^9/L, PLT>50×10^9/L, TBIL<1.5 times of upper limit of normal reference value, ALT and AST<2.5 times of upper limit of normal reference value(Liver metastasis: <5×ULN), and CR=1.25 ×ULN; 10. Patients will take contraceptive measures for the duration of the treatments and 8 weeks after the last treatment; 11. Signed the Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1. Any local treatment other than TILA-TACE (including but not limited to surgery, radiotherapy, hepatic artery infusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) was received within four weeks before screening; 2. Hepatobiliary cell carcinoma and mixed cell carcinoma are known; previous (5 year) or at the same time suffering from other incurable malignancies, except for the cured basal cell carcinoma of the skin and cervical carcinoma in situ; 3. Patients are preparing for liver transplantation (excepting those who have had previous liver transplantation); 4. Uncontrollable ascites, hepatic encephalopathy or bleeding of esophageal and gastric fundus varices; 5. Patients with poor blood pressure control (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg ); 6. Patients with stage II myocardial ischemia or myocardial infarction, poor control of the arrhythmia (including QT interval male = 450 ms, female = 470 ms) and Grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)1.5, APTT>1.5 UNL) or bleeding tendency; 11. Patients with central nervous system metastasis or known brain metastases; 12. Patients with objective evidence of the history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe lung impairment; 13. Patients whose routine urine tests indicate that urine protein = ++ or verifies that the 24-h urine protein quantitation = 1.0 g; 14. Receiving potent CYP3A4 inhibitors within 7 days before screening, or potent CYP3A4 inducers within 12 days before screening; 15. Pregnant and lactating women; 16. Patients with a history of mental illness or psychotropic substance abuse; 17. Patients with bone metastases had received palliative radiation therapy (radiation Therapy Area > 5% of bone marrow area) within 4 weeks before screening; 18. Patients infected with union HIV.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TTP; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;PFS;ORR;DCR; | — |
Countries
China
Contacts
Public ContactMing Chao
The Second Affiliated hospital of Zhejiang University School of Medicine
Outcome results
None listed