- In a phase 2 trial, perioperative immunotherapy was safe and led to pathologic complete response (pCR) in 37.5% of patients with resectable hepatocellular carcinoma (HCC), supporting its use as a perioperative treatment in this patient population.
Why this matters
- In HCC, surgical resection is associated with a high rate of recurrence.
- There are currently no effective adjuvant or neoadjuvant therapies for HCC.
- Randomized, open-label, single-institution phase 2 trial
- 9 patients received either nivolumab (240 mg every 2 weeks for 6 weeks) or nivolumab + ipilimumab (1 mg/kg every 6 weeks).
- Patients underwent surgical resection within 4 weeks after last therapy cycle and continued immunotherapy for up to 2 years postresection.
- Primary endpoints were safety and tolerability.
- 5 patients in nivolumab arm and 3 in nivolumab + ipilimumab arm were evaluable.
- 3 patients (37.5%) achieved pCR (2 in nivolumab arm, 1 in nivolumab + ipilimumab arm).
- pCR was associated with a significant increase in 2 CD8+ T cell clusters, as well as in Teff/Treg ratio.
- Treatment was safe, and did not lead to delays in resection.
- Pilot trial, still ongoing.