Hepatocellular Carcinoma
Conditions
Brief summary
The purpose of this study is to evaluate the resectability after treatment with SECOX (sorafenib, capecitabine, oxaliplatin) as neoadjuvant therapy in patients with locally advanced hepatocellular carcinoma
Interventions
DRUGSorafenib
PO
DRUGCapecitabine
PO
DRUGOxaliplatin
IV
Sponsors
The University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* HCC confined to single lobe of non-cirrhotic liver (locally advanced) and not suitable for surgery or loco-regional therapies at the time of study entry, but can become resectable after treatment * Diagnosis of HCC confirmed by histology * Child-Pugh class A cirrhosis with adequate remnant liver parenchyma * Measurable disease * Fit enough to undergo surgery to resect the primary liver tumour
Exclusion criteria
* Prior systemic therapy for HCC * Presence of extrahepatic metastasis * History of liver transplantation * Peripheral sensory neuropathy with functional impairment * Uncontrolled hypertension/ cardiac disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resectability | At the end of Cycle 4 (each cycle is 14 days) | Proportion of patients deemed resectable as assessed by designated hepatobiliary surgeons |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | At the end of Cycle 4 (each cycle is 14 days) | Proportion of patients with a complete response (CR) or partial response (PR) |
| Progression-free survival | Approximately 18 months | Time from study treatment to radiological disease progression or death due to any causes |
| Overall survival | Approximately 33 months | Time from study treatment to the date of death due to any cause or last follow-up date |
Countries
Hong Kong
Outcome results
None listed