Hepatocellular Carcinoma
Conditions
Brief summary
evaluate the effect of different oxaliplatin dose in TAI in treating unresectable HCC.
Interventions
PROCEDUREtransarterial infusion
transarterial infusion
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* older than 18 years old and younger than 75 years; * ECOG PS≤1; * proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria; * not previous treated for tumor; * unresectable; * the lab test could meet: neutrophil count≥2.0×109/L; hemoglobin≥100g/L; platelet count≥75×109/L; serum albumin≥35g/L; total bilirubin\<2-times upper limit of normal; ALT\<3-times upper limit of normal; AST\<3-times upper limit of normal; serum creatine\<1.5-times upper limit of normal; PT≤upper limit of normal plus 4 seconds; INR≤2.2; * sign up consent
Exclusion criteria
* cannot tolerate TAI or surgery; * known history of other malignancy; * be allergic to related drugs; * underwent organ transplantation before; * be treated before (interferon included); * known history of HIV infection; * known history of drug or alcohol abuse; * have GI hemorrhage or cardiac/brain vascular events within 30 days; * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OS | From date of randomization until the date of death from any cause, assessed up to 60 months | overall survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | From date of randomization until the date of death from any cause, assessed up to 60 months | object response rate |
| PFS | From date of randomization until the date of progress from any cause, assessed up to 60 months | progression-free survival |
Countries
China
Outcome results
None listed