4.6. Study Design
hepatitis B-related HCC
This clinical study was designed as a Phase I/II trial. The Phase I study aimed to evaluate the safety and tolerability and define the MTD of the sequential administration of ropeginterferon alfa-2b and nivolumab in patients who received curative surgery for hepatitis B-related HCC. The Phase II trial was designed to further evaluate the safety and prophylactic effect of the sequential administration of ropeginterferon alfa-2b and nivolumab at the MTD. Phase I was conducted at the National Taiwan University Hospital (NTUH), Taiwan (approval number: 201710061MIPB). The Phase I study was completed, but the Phase II study has not yet started.Sequential administration of ropeginterferon alfa-2b and nivolumab was assessed using a 3 + 3 dose escalation scheme. Eligible patients were enrolled in four dose cohorts to receive six doses of ropeginterferon alfa-2b at a dose of 450 μg once every two weeks, followed by three doses of nivolumab every two weeks at a predetermined dose level based on the cohort, including 0.3 mg/kg for Cohort 1; 0.75 mg/kg for Cohort 2; 1.5 mg/kg for Cohort 3; and 3 mg/kg for Cohort 4. Ropeginterferon alfa-2b was administered via subcutaneous injection, and nivolumab was administrated through intravenous infusion over 60 min [