Liver cell cancer
Conditions
Interventions
A:GEM 1000mg/m2 d1, I.V.ggt30-60/min
B:Sorafenib 400mg bid po
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) To be aged >=18years; 2) ECOG: 0-1 points; 3) Participant with primary liver cell cancer confirmed by the histology/cytology or iconography unable to resection; typical imaging appearances of primary liver cell cancer, such as CTHA/CTAP or MRI; 4) Predictive life span no less than 12 months; 5) Patients without systemic chemotherapy and Sorafenib in history; 6) To be with at least one sagittal and coronary measurable lesions, include at least one measurable lymph node; 7) Patients without radiotherapy in last 6 weeks and surgery history in last 3 weeks; 8) Patients with the liver function by the Child-pugh class A. 4 weeks before enrollment had received local therapeutics, including: radiotherapy, HAE, Chemoembolization, RFCA, percutaneous ethanol injection, cryoablation; addition to receiving local treatment of lesions, there are other measurable original lesion or lesions of disease progression were included in the study; 9) Patients with recurrence or metastasis after surgery; 10) Exophageal varices without ulcer and activity bleeding confirmed by the gastroscope; 11) Patients in anticoagulant therapy with deep venous thrombosis, coagulation function is normal; 12) Biochemistry indx: Blood cell count: N>=1.0*10^9/L; PLT>=75*10^9/L; HB>=85g/L; Liver function: TBiL=28g/L, AST<5 times the normal cap; Kidney function: SCr<1.5 times the normal cap; Coagulation function: INR<=2.3; PT delay 0-6 seconds more than normal; 13) Voluntary and signed informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients with pathomorphological classification and clinical stages which can not meet the inclusion criteria; 2) Patients with systemic chemotherapy or Sorafenib in history; 3) Patients with any acute or chronic diseases; 4) A patient with serious cardiovascular disease in 12 months, including: intractable hypertention; unstable angina; myocardial infarction; uncontroled arrhythmia; 5) A patient gonna to have sugery in 4 weeks; 6) A patient with active ulcer; 7) A patient with active bleeding; 8) A patient with serious proteinuria >=2g/24h; 9) Unassess or unmeasure lesions; 10) A patient on the treatment of anticancer; 11) Uncontroled central nervous system metastases; 12) A patiens with uncontroled serious infection diseases, or serious metabolic disease ; 13) A patient with history of another malignant disease, except curatively treated basal cell carcinoma of the skin and carcinoma in situ of cervix are excluded; 14) Have biological agents allergy history, allergic constitution or is in a state of allergy patients; 15) Compliance dealing; 16) pregnancy and lactation women; 17) Patients inappropriate for this trail; 18) Did not signed an informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total survival time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Security of Sorafenib for HCC;TTP; | — |
Countries
China
Contacts
Public ContactWang Jufeng
Outcome results
None listed