Work

Gemcitabine plus cisplatin versus gemcitabine as adjuvant therapy after curative-intent resection of cholangiocarcinoma (GeCiCCA): a multicenter, randomized controlled, phase III trial

Year: 2026

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: This randomized controlled trial aims to evaluate whether adjuvant gemcitabine plus cisplatin improves overall survival compared to gemcitabine monotherapy in patients with resected cholangiocarcinoma (CCA). Secondary outcomes include assessment of disease-free survival, treatment safety, and adherence. This phase III, multicenter, open-label randomized controlled trial planned to enroll 320 patients with resected CCA. Eighty patients were randomized to receive either gemcitabine plus cisplatin or gemcitabine monotherapy (40 per group). Recruitment was terminated prematurely because of slow accrual and the absence of a clear benefit signal in preliminary efficacy data. Outcomes including overall survival, disease-free survival, and safety were assessed. At a median follow-up of 83.5 months (95% CI, 73.8–91.2), data were censored on 30 January 2025. A total of 45 deaths (56.3%) were documented. Median overall survival was 68.9 months in the gemcitabine–cisplatin group compared with 49.1 months in the gemcitabine group; however, the difference was not statistically significant (hazard ratio [HR], 0.87; 95% CI, 0.48–1.58; P = 0.654). Similarly, median DFS did not differ significantly between gemcitabine plus cisplatin (36.6 months) and gemcitabine alone (36.2 months) (HR, 0.87; 95% CI, 0.49–1.53; P = 0.624). Exploratory subgroup analyses showed no statistically significant differences between treatment groups. Treatment adherence was lower in the combination group than in the monotherapy group (65.0% vs. 92.5%). Grade 3–4 adverse events were more frequent with combination therapy (77.5% vs. 70%), with higher rates of nephrotoxicity and hepatotoxicity observed. This trial did not demonstrate an improvement in OS or DFS with the addition of cisplatin. The small sample and wide confidence intervals preclude definitive conclusions about comparative efficacy and do not establish equivalence. Treatment completion was lower with combination therapy, and several adverse events were more frequent.

Source: World Journal of Surgical Oncology

DOI: 10.1186/s12957-026-04637-4