Perioperative nivolumab monotherapy versus nivolumab plus ipilimumab in resectable hepatocellular carcinoma: A randomized, open-label, phase 2 trial

The Lancet: Gastroenterology & HepatologyKaseb AO, Hasanov E, Cao HST, et al. | February 11, 2022

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In advanced hepatocellular carcinoma, immunotherapy has been linked with improved survival. Researchers conducted this single-center, randomized, open-label, phase 2 trial, with the aim to examine the safety and tolerability of perioperative immunotherapy in resectable hepatocellular carcinoma.

  • Researchers randomly assigned patients with resectable hepatocellular carcinoma (1:1) to receive 240 mg of nivolumab intravenously every 2 weeks (for up to three doses before surgery at 6 weeks) followed in the adjuvant phase by 480 mg of nivolumab intravenously every 4 weeks for 2 years, or 240 mg of nivolumab intravenously every 2 weeks (for up to three doses before surgery) plus one dose of 1 mg/kg of ipilimumab intravenously concurrently with the first preoperative dose of nivolumab, followed in the adjuvant phase by 480 mg of nivolumab intravenously every 4 weeks for up to 2 years plus 1 mg/kg of ipilimumab intravenously every 6 weeks for up to four cycles.

  • Overall, there was enrollment of 30 patients, 27 of whom were randomly assigned: 13 to nivolumab and 14 to nivolumab plus ipilimumab.

  • Nivolumab plus ipilimumab correlated with occurrence of higher grade 3–4 adverse events (six [43%] of 14 patients) compared with nivolumab alone (three [23%] of 13).

  • Surgery was not delayed in any of the patients in either group due to grade 3 or worse adverse events.

  • In patients with resectable hepatocellular carcinoma, it seems to be safe and feasible to administer perioperative nivolumab alone and nivolumab plus ipilimumab.

  • This work yields support for conducting further studies of immunotherapy in the perioperative setting in hepatocellular carcinoma.

Read the full article on The Lancet: Gastroenterology & Hepatology

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