This is a phase 2, single-arm trial designed to assess the clinical benefit of treatment with nivolumab administered in patients with untreated, borderline resectable HCC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
3 mg/kg on Day 1 of each 2-weekly cycle for 3 doses
Hepatectomy will be performed approximately 2 weeks after the 3rd dose of nivolumab
Queen Mary Hospital
Hong Kong, Hong Kong
Pathological tumour response rate
Proportion of patients with resected tumours having ≥30% necrosis
Time frame: After surgery (normally 6 weeks after the start of nivolumab)
Recurrence-free survival
The time from resection to disease recurrence or death from any cause
Time frame: At least 3 months after surgery
Overall survival
The time from start of treatment to the date of death from any cause or last follow-up date
Time frame: At least 3 months after surgery
Short-term surgery outcomes
Operation time, blood loss during surgery, transfusion requirement during surgery, and complication rate within 2 weeks following surgery
Time frame: 2 weeks after surgery
Safety and tolerability of nivolumab
The incidence, severity as graded by NCI CTCAE v5.0, seriousness and relationship to study medication of adverse events (AEs)
Time frame: 6 months
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