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| Home > Publications database > Adjuvant chemotherapy with cisplatin and gemcitabine compared to standard of care after curative intent resection of cholangiocarcinoma and muscle invasive gallbladder carcinoma (ACTICCA-1/AIO-HEP-0112 trial). |
| Home > Publications database > Adjuvant chemotherapy with cisplatin and gemcitabine compared to standard of care after curative intent resection of cholangiocarcinoma and muscle invasive gallbladder carcinoma (ACTICCA-1/AIO-HEP-0112 trial). |
| Journal Article | DKFZ-2026-02693 |
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2026
Elsevier
Amsterdam [u.a.]
Abstract: Despite curative resection and adjuvant capecitabine, about 50% of biliary tract cancer (BTC) patients have tumour recurrence or die within two years. Combination chemotherapy with cisplatin and gemcitabine (CisGem) is an established palliative chemotherapy regimen BTC, which has been evaluated in the adjuvant setting here.ACTICCA-1 is a randomized, phase III investigator-initiated trial. Patients were enrolled at 67 sites across 8 countries between September 2017 and January 2023 and randomized to CisGem or capecitabine as adjuvant treatment regimen, each for a planned duration of 24 weeks. The primary endpoint is disease-free survival (DFS). Secondary endpoints include overall survival, safety and tolerability.591 patients have been randomized. Median follow-up was 4.8 years. Median age was 63, 46.9% were female, and median interval between surgery and enrolment was 67 days. Primary tumour location was intrahepatic in 28.3%, perihilar in 19%, distal in 36.5%, and gallbladder in 16.2%, 47.9% of patients had lymph node positive disease (N+). CisGem showed a median DFS of 25.7 months compared to 17.9 months for capecitabine (log rank p=0.097). As pre-defined in the statistical analysis plan (SAP), due to violation of proportional hazard assumption a Cox model was not feasible and restricted mean survival time (RMST) was analysed. Patients receiving CisGem experienced on average 2.6 additional DFS months (95% CI 0.6-4.68) compared to capecitabine (RMST in the first 3 years, p=0.011), but no significant improvement in overall survival (RMST p=0.076; median 58.1 vs. 48.2 months). Toxicity showed a higher number of Severe Adverse Events (SAE) (130 vs. 113 with 51 vs. 47 assessed as treatment related) and a higher AE rate of 74.7% vs. 69.5% with CisGem compared to capecitabine.CisGem did not statistically improve DFS compared to capecitabine and should thus not be applied as standard of care in the adjuvant setting.The study is registered with ClinicalTrials.gov (NCT02104882) and the EudraCT Nr: 2012-005078-70 / EU-CT-Nr.: 2024-517340-61-00.
Keyword(s): adjuvant ; biliary tract cancer ; capecitabine ; chemotherapy ; cisplatin ; gemcitabine
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