hepatocellular carcinoma(HCC)
Conditions
Interventions
experimental group:Oligo-Fucoidan powder 4.4g, B.I.D. for six months
control group:Cellulose powder 4.4g, B.I.D. for six months
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged > 18 years; 2. ECOG PS 0-2; 3. Histologically or cytologically documented unresectable HCC; 4. Measurable disease by RECIST criteria; 5. Previous local therapy completed > 6 weeks; 6. Any acute toxicity (CTC-AE) = 2.8 g/dl; 9. Serum total bilirubin = 3,000/µl; 12. ANC >= 1,500/µl; 13. Platelets = 100,000/µl; 14. Hb >= 8.5 g/dl; 15. Creatinine <= 1.5 x ULN; AND; 16. Amylase and lipase < 1.5 x ULN.
Exclusion criteria
Exclusion criteria: 1. Metastatic tumors; Prior or concomitant systemic anti-cancer treatment for HCC, including: (1) Systemic chemotherapy (TACE is allowed); (2) Immunotherapy; (3) Hormonal therapy (hormonal therapy for supportive use is allowed); (4) Raf-kinase inhibitors; (5) MEK inhibitors; (6) Farnesyl transferase inhibitors; (7) VEGF/VEGFR- inhibitors or other anti-angiogenesis agents; (8) Investigational anti-cancer agents; 2. Severe and/or uncontrolled medical conditions: (1) Uncontrolled high blood pressure; (2) History of poor compliance with anti-hypertensive agents; (3) Active or uncontrolled infection; (4) Unstable angina; (5) CHF; (6) MI or CVA grade 2; (10) BMT or stem cell rescue < 4 months; organ transplant; (11) HIV infection; (12) Major surgical procedure, open biopsy, or significant traumatic injury < 4 weeks or those who receive minor surgical procedures (e.g. core biopsy or fine needle aspiration) within 2 weeks; (13) Patients taking narrow therapeutic index medications will be monitored closely. These include warfarin, phenytoin, quinidine, carbamazepine, phenobarbital, cyclosporine, and digoxin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR) [RECIST 1.1]; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate(ORR);Progression free survival (PFS);Overall survival (OS);Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 & European Organization for Research and Treatment of Cancer (EORTC);QLQ-C30 (Quality of life);Incidence of Treatment-Emergent Adverse Events (Safety); | — |
Countries
China
Contacts
Public ContactShen Xizhong
Zhongshan Hospital Affiliated to Fudan University
Outcome results
None listed