HepatoCellular Carcinoma
Conditions
Brief summary
The current random, double-blind, controlled, clinical trial was designed to evaluate the impact on therapeutic effect and tolerance of treatment for patients with hepatocelluclar carcinoma in transcatheter arterial chemoembolization (TACE) of dexamethasone application.
Interventions
DRUGDexamethasone
use dexamethasone 10mg (2ml) I.A. during TACE
DRUGNormal Saline
use normal saline 2ml I.A. during TACE
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* older than 18 years old; * ECOG PS\<3; * proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria; * meeting at least 1/4: 1) multiple nodules, 2) single tumor but not suitable for resection, 3) vascular invasion exists, 4) distant metastasis excluding CNS and bone * not previous treated for tumor; * Child-Pugh A or B; * at least one measurable lesion according mRECIST; * cannot afford sorafenib; * the lab test could meet: neutrophil count≥1.5×109/L; hemoglobin≥80g/L; platelet count≥60×109/L; serum albumin≥28g/L; total bilirubin\<3-times upper limit of normal; ALT\<5-times upper limit of normal; AST\<5-times upper limit of normal; serum creatine\<1.5-times upper limit of normal; PT≤upper limit of normal plus 6 seconds; INR≤2.3 * sign up consent; * unrolled by other clinical trials about hepatocellular carcinoma.
Exclusion criteria
* cannot tolerate TACE; * CNS or bone metastasis exits; * 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 hemorrage or cardiac/brain vascular events within 30 days; * pregnancy;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate (RR) | 1 month after TACE |
| proportions of participants with severe adverse events according to CTCAE v4.03 | 1 month after TACE |
Secondary
| Measure | Time frame |
|---|---|
| overall survival (OS) | From date of randomization until the date of death from any cause, assessed up to 60 months |
| progression-free survival (PFS) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months |
| time to progression (TTP) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months |
Countries
China
Contacts
Primary ContactShaohua Li, MD
Outcome results
None listed