A Novel Adjuvant Chemoradiotherapy/Immunotherapy for Resected Biliary Cancer
Mené sur 93 patients atteints d'un cholangiocarcinome extrahépatique ou d'un cancer de la vésicule biliaire (durée médiane de suivi : 36 mois), cet essai randomisé évalue l'efficacité, du point de vue de la survie globale, et la sécurité d'une immunothérapie par camrélizumab en combinaison avec une chimioradiothérapie à base de capécitabine
In this issue of JAMA Oncology, Xiao et al report the results of a phase 2 randomized clinical trial investigating a combination of immunotherapy and chemoradiotherapy as adjuvant therapy following resection of extrahepatic cholangiocarcinoma (EHC) and gallbladder cancer (GBC). An important aspect of the study was that the authors limited inclusion to these 2 subtypes of biliary cancer given the recent recognition of molecular differences between EHC/GBC and intrahepatic cholangiocarcinoma.A total of 93 patients with nonmetastatic cancer after R0 or R1 resection with pT2-4 or pN1 disease were randomized to no therapy or a combination of camrelizumab and capecitabine-based chemoradiotherapy. The study was well-conducted, with appropriate inclusion criteria and an adequate follow-up period. The authors report that this adjuvant regimen resulted in a significant increase in overall survival (OS) and relapse-free survival (hazard ratios of 0.43 and 0.46, respectively). This was statistically significant and clinically meaningful with survival at 3 years improving from 30.5% to 58.2%. Toxicity was as expected and acceptable. The results strongly suggest that this is an active regimen in the adjuvant setting and represent a welcome and important contribution to the field.
JAMA Oncology , éditorial, 2025