Hepatocellular Carcinoma
Conditions
Brief summary
This trial is a multi-center, phase III, randomized (1:1) clinical trial. The aim is to explore the efficacy and safety of Sorafenib combined with transarterial chemoembolization as adjuvant treatment for resectable advanced hepatocellular carcinoma, compared with Sorafenib alone. The primary endpoint is recurrence-free survival. This trial planned to recruit 158 patients who received curative hepatic resection with resectable advanced hepatocellular carcinoma. The patients will be randomized into Sorafenib group and Sorafenib+TACE group as 1:1 ratio.
Interventions
DRUGSorafenib
Sorafenib is one of tyrosine kinase inhibitors. The initial dosage is 400mg orally, twice daily.
PROCEDURETransarterial chemoembolization
TACE including conventional TACE (cTACE) and DEB-TACE. Treatment choices are according to the specific condition of each patient and the experience of interventional radiologists.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Primary hepatocellular carcinoma without any treatments. 2. Received curative hepatic resection 3. ECOG score 0-1 4. Child-Pugh grade A 5. Sufficient liver and kidney function
Exclusion criteria
1. Diffused lesions; tumor thrombosis in SMV or IVC. 2. Extra-hepatic metastasis. 3. Contraindication of TACE, like portal-systemic shunt, obvious atherosclerosis, etc. 4. Allergic to the contrast agent of TACE 5. Dysfunction of liver, kidney or bone marrow. 6. Concomitant other malignant tumor or HIV infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence-free survival | 2 years | Recurrence-free survival indicates the interval between randomization and tumor recurrence or death.\[0-2 years\] Longer RFS time indicates better prognosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 2 years | Overall survival indicates the interval between randomization and death.\[0-2years\]Longer OS time indicates better prognosis. |
| Time to recurrence | 2 years | Time to recurrence indicates the interval between randomization and tumor recurrence.\[0-2years\]Longer TTR time indicates better prognosis. |
| Severe adverse events | 2 years | Incidence rate of severe adverse events. \[0-100%\]. lower rate indicates more safety of the treatment |
| Quality of life | 2 years | Questionnaire score of EORTC-QOL. Higher score indicates better quality of life |
Countries
China
Contacts
Primary ContactMing Kuang, MD, PhD.
Outcome results
None listed