Hepatocellular Carcinoma
Conditions
Interventions
Case series:None
Sponsors
Ethics Committee of 81st Hospital of Chinese PLA
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male or female; 2. From 18 to 70 years old; 3. Histologically, cytologically diagnosed HCC which are ineligible for curative resection and local treatment; 4. Or clinically diagnosed HCC which are ineligible for curative resection or local treatment; 5. Or patients with histologically, cytological or clinically diagnosed HCC who are not willing to accept resection and local treatment; 6. Physicians intention to treat with Eloxatin/Fluorouracil based systemic chemotherapy; 7. Signed informed consent form (ICF) prior to study entry.
Exclusion criteria
Exclusion criteria: 1. Patients who are receiving any other study treatments or experimental medical treatment within 30 days prior to study entry; 2. Documented allergy to platinum compound; 3. Pregnant or lactating women or women of childbearing potential without proper contraceptive methods.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The frequency of drug-related high-grade (Grade 3 and 4) liver toxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| The frequency and severity of all other adverse events (AE);Overall Survival (OS);Progression Free Survival (PFS);Objective Response Rate (ORR);Disease Control Rate (DCR);Number of cycles;Dose-intensity;Relative dose-intensity; | — |
Countries
China
Contacts
Public ContactQin Shukui
SANOFI (CHINA) INVESTMENT CO., LTD.
Outcome results
None listed