Single-center phase 2 trial of adjuvant camrelizumab plus capecitabine ater surgical resection for intrahepatic cholangiocarcinoma

Patients with intrahepatic cholangiocarcinoma (ICC) have a poor prognosis and high postoperative recurrence rates. The phase 2 ACC trial at Zhongshan Hospital of Fudan University (Shanghai, China) evaluated the adjuvant combination of camrelizumab and capecitabine after surgical resection of ICC. Eligible patients had no extrahepatic metastases, an ECOG performance status 0 or 1, and adequate organ function. The study included 65 patients (62% male; median age 64 years; IQR 54-70). After median follow-up of 33.7 months (IQR 24.9-40.0), recurrence was seen in 36 patients (55%): 24 (67%) with intrahepatic recurrence only, six (17%) with both intrahepatic and extrahepatic recurrence, and six (17%) with extrahepatic recurrence only. Median recurrence-free survival was 24.3 months (95% CI 13.5-NR). Grade 3 treatment-related adverse events occurred in 15 patients (23%); serious TRAEs were reported in four patients (6%); no grade 4 or 5 TRAEs occurred. The authors conclude that the adjuvant combination of camrelizumab and capecitabine showed promising activity with an acceptable safety profile among patients with resected ICC.