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Perioperative nivolumab monotherapy vs 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. | January 21, 2022

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Although there are high recurrence rates of hepatocellular carcinoma following surgery, no standard-of-care neoadjuvant or adjuvant therapies have been approved. In view of studies describing immunotherapy as efficacious in improving survival in advanced hepatocellular carcinoma, researchers herein sought to evaluate the safety and tolerability of perioperative immunotherapy in resectable hepatocellular carcinoma.

  • A single-center, randomized, open-label, phase 2 trial, was conducted enrolling 30 patients; of these, 27 were randomly assigned 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.

  • Increased alanine aminotransferase (three [23%] of 13 patients on nivolumab vs seven [50%] of 14 patients on nivolumab plus ipilimumab) and increased aspartate aminotransferase (three [23%] vs seven [50%]) were identified to be the most common treatment-related adverse events of any grade.

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

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

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