hepatocellular carcinoma
Conditions
Interventions
Part I: Group A :sorafenib in combination with entecavir
Part I: Group B :sorafenib
Part II: Group C:SOX regimen in combination with entecavir
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Advanced unresectable and/or metastasis) HCC, defined as: Histologically or cytologically or clinically diagnosed HCC: meet the following conditions (1)+(2)a, or conditions(1)+(2)b+(3): (1) With evidence of cirrhosis and HBV and/or HCV infection; (2) A typical imaging features of HCC using multidetector CT scan and/or dynamic contrast-enhanced MR: hypervascular in the arterial phase with washout in the portal venous or delayed phases; a. While one of the two imaging techniques is required for nodules more than 2cm in diameter; b. A more conservative approach with 2 techniques is recommended for nodules between 1 and 2cm in diameter. (3) Serum AFP more than 400ug/L for 1 month or Serum AFP more than 200ug/L for 2 months, and can also rule out other reasons of AFP elevating, including pregnancy, embryonic germline tumors, active liver disease and secondary liver cancer, etc. 2. HBsAg positive, HBV DNA less than 1*10^4 copies/mL; 3. At least one measurable lesion according to RECIST 1.1. At least one target lesion previous no treated with any local therapy (surgery, radiotherapy, transcatheter arterial embolization (TAE), transarterial chemoembolization (TACE), radiofrequency ablation, percutaneous ethanol injection, or cryoablation); 4. Part I(Sorafenib): metastatic lesions previous were no treated with sorafenib and systemic chemotherapy. Part II (Chemotherapy): metastatic lesions previous were no treated with systemic chemotherapy, or previous adjuvant chemotherapy had to have been completed longer than 12 months; and previously treated with sorafenib or can not be tolerated with sorafenib; 5. Age older than 18 years; 6. Can be administered orally; 7. ECOG Performance Status of 0 or 1; 8. Child-Pugh A and B; 9. BCLC stage B-C; 10. Life expectancy of at least 12 weeks; 11. Adequate main organ function as assessed by the following; a) Absolute neutrophil count (ANC) more than 1.5*10^9/L; b) Platelet count more than 75*10^9/L; c) ALB more than 29g/L; d) ALT, AST, Alkaline phosphatase less than 2.5 * upper limit of normal (UNL); e) Total bilirubin less than 1.5 UNL; f) Serum creatinine less than 1.5 UNL; g) INR less than 1.5. -Patients voluntary sign written informed consent -Patients voluntary choose sorafenib or chemotherapy
Exclusion criteria
Exclusion criteria: 1. Previously received chemotherapy; 2. Prior local therapy (surgery, radiotherapy, transcatheter arterial embolization(TAE), transarterial chemoembolization (TACE), radiofrequency ablation, percutaneous ethanol injection, or cryoablation) within weeks; 3. Suffered other malignancies within five years, except cervical carcinoma in situ or basal cell carcinoma; 4. Received other study drugs 4 weeks before our study; 5. Pregnant or breast-feeding patients; 6. With a history or clinical evidence of brain metastases; 7. Patients receiving anticoagulant therapy, or receiving antiretroviral therapy because of HIV; 8. With severe uncontrolled systemic complications, such as infection or poor control of diabetes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part I: Overall survival;Part II: Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Part I: Progression free survival;Part I: Objective response rate;Part I: Hepatitis B viral recurrence rate;Part II: Overall survival;Part II: Objective response rate;Part II: Hepatitis B viral recurrence rate; | — |
Countries
China
Contacts
Public ContactLi Qiu
Outcome results
None listed