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Adding cisplatin to gemcitabine doesn't outperform capecitabine after surgery for biliary tract cancer. The phase 3 ACTICCA-1 trial, presented at ESMO 2026, found no statistically significant disease-free survival advantage with the combination regimen — though it came with more side effects. Capecitabine remains the standard of care in the adjuvant setting.
A major phase 3 trial has found that combining cisplatin and gemcitabine doesn't meaningfully outperform capecitabine as adjuvant chemotherapy for patients with cholangiocarcinoma (CCA) or gallbladder carcinoma after surgery. The ACTICCA-1 trial, presented at ESMO Congress 2026 and simultaneously published in Annals of Oncology, enrolled 601 patients across eight countries who had undergone curative-intent resection of their tumors.
The trial aimed to show a 9.3% improvement in 24-month disease-free survival (DFS) with the combination regimen — a threshold considered clinically meaningful. It fell short: DFS rates were 52% vs. 44% in favor of cisplatin-gemcitabine, but the difference didn't reach statistical significance. A secondary analysis using restricted mean survival time showed a modest 2.6-month DFS benefit at 3 years, though overall survival differences also remained non-significant.
By the Numbers:
Why it matters: Biliary tract cancers are aggressive and have limited treatment options post-surgery. While cisplatin-gemcitabine showed some numerical advantages, its increased toxicity and failure to hit the primary endpoint mean capecitabine stays the standard — though shared decision-making may still bring the combo into play for select patients.
