A new multicentre trial has found that combining chemoradiation with immunotherapy significantly improves survival in patients with resectable extrahepatic cholangiocarcinoma (EHC) and gallbladder cancer (GBC) — two aggressive and hard-to-treat biliary tract cancers.
The ACCORD randomised clinical trial, led by Dr Han Xiao and colleagues, enrolled 93 patients who had undergone curative-intent surgery. Participants were randomised to receive either camrelizumab plus concurrent capecitabine and radiotherapy or standard observation. After a median follow-up of 36 months, patients receiving the combination treatment demonstrated markedly better outcomes.
Overall survival (OS) at three years was 58.2% in the combination group compared with 30.5% in the observation group (hazard ratio 0.43; P = 0.004). Similarly, recurrence-free survival (RFS) was almost doubled, with a median RFS of 26 months versus 13 months.
Importantly, the treatment was well tolerated. All patients completed chemoradiation, and only 13% experienced minor delays in immunotherapy. Severe adverse events were manageable, with no treatment-related deaths reported.
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“The combination of camrelizumab with chemoradiation was not only effective but also highly tolerable,” the authors stated. “These results provide robust evidence for a new adjuvant treatment strategy in a cancer type where options have historically been very limited.”
“These results provide robust evidence for a new adjuvant treatment strategy in a cancer type where options have historically been very limited.”
EHC and GBC together account for over 70% of biliary tract cancers, which have notoriously poor survival rates even after surgery. This trial suggests that integrating immunotherapy with standard adjuvant chemoradiation could become a new standard of care for these patients, pending further validation in larger, diverse populations.
Paper: Xiao HJi JLi S, et al. Adjuvant Chemoradiation and Immunotherapy for Extrahepatic Cholangiocarcinoma and Gallbladder Cancer: A Randomized Clinical Trial. JAMA Oncol. 2025;11(9):1021–1029. doi:10.1001/jamaoncol.2025.1926 Access online here.
