# ACTICCA-1

Source: https://onco.cc/trials/acticca-1/  
OnCo record `acticca-1` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

ACTICCA-1 asks whether six months of gemcitabine and cisplatin after surgery beats the current standard for bile duct and gallbladder cancer. It recruited 789 patients across eight countries including 24 UK hospitals, has a separate gallbladder cohort, and finished recruiting; results are awaited.

## Summary

ACTICCA-1 (NCT02170090) is an investigator-initiated, multinational randomised phase 3 trial led from Hamburg-Eppendorf and funded by Deutsche Krebshilfe, the Dutch Cancer Society and, for the UK sites, Cancer Research UK. Patients with histologically confirmed adenocarcinoma of the biliary tract (intrahepatic, hilar or extrahepatic cholangiocarcinoma, or muscle-invasive gallbladder carcinoma) after macroscopically complete resection were randomised within 16 weeks of surgery to gemcitabine and cisplatin for 24 weeks or to the standard of care, which was observation when the trial opened in 2014 and became capecitabine after BILCAP. The protocol enrolled cholangiocarcinoma and gallbladder carcinoma as two separate cohorts with their own sample sizes (271 and 154 evaluable patients) because of their different prognosis, stratified by nodal status; the primary endpoint is disease-free survival with overall survival, safety, quality of life and recurrence pattern as secondary endpoints. The registry records 789 patients enrolled at 67 sites in Australia, Austria, Denmark, Germany, Italy, the Netherlands, New Zealand and the United Kingdom, with primary completion in December 2025 and the trial active but no longer recruiting. No results were found in Europe PMC or on the registry in September 2026. For gallbladder cancer this is the only phase 3 with a dedicated cohort testing platinum doublet chemotherapy against capecitabine after surgery.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-24
- Registry id: NCT02170090
- Phase: 3
- Setting: Adjuvant gemcitabine and cisplatin for 24 weeks versus standard of care (observation, later capecitabine) after curative-intent resection of cholangiocarcinoma or muscle-invasive gallbladder carcinoma, in two separate cohorts
- Sponsor: Universitätsklinikum Hamburg-Eppendorf
- Enrolled: 789

## Notes

- Key facts: adjuvant gemcitabine and cisplatin for 24 weeks versus standard of care (observation, then capecitabine after BILCAP) within 16 weeks of macroscopically complete resection; two cohorts with separate sample sizes (cholangiocarcinoma 271 and muscle-invasive gallbladder carcinoma 154 evaluable) stratified by nodal status; primary endpoint disease-free survival; 789 enrolled at 67 sites in eight countries; primary completion December 2025; no results in Europe PMC or on the registry in September 2026. UK sites funded by Cancer Research UK.
- UK sites (24, registry): Hampshire Hospitals (Basingstoke), Queen Elizabeth Hospital Birmingham, Royal Bournemouth Hospital, Bristol Haematology and Oncology Centre, Addenbrooke's Cambridge, Velindre Cardiff, Western General Edinburgh, Beatson Glasgow, James Paget (Great Yarmouth), Royal Surrey Guildford, Princess Alexandra Harlow, Huddersfield Royal Infirmary, Guy's and St Thomas' London and others.

## Sources

- ClinicalTrials.gov NCT02170090: https://clinicaltrials.gov/study/NCT02170090
- Stein et al., BMC Cancer 2015: ACTICCA-1 protocol: https://doi.org/10.1186/s12885-015-1498-0

## Connected records

- trials: [BILCAP](https://onco.cc/trials/bilcap/)
- cancers: [Biliary tract cancer (all types)](https://onco.cc/cancers/biliary-tract-cancer/), [Biliary tract cancer (cholangiocarcinoma)](https://onco.cc/cancers/cholangiocarcinoma/), [Extrahepatic cholangiocarcinoma (perihilar and distal)](https://onco.cc/cancers/extrahepatic-cholangiocarcinoma/), [Gallbladder cancer](https://onco.cc/cancers/gallbladder/), [Intrahepatic cholangiocarcinoma](https://onco.cc/cancers/intrahepatic-cholangiocarcinoma/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Platinum agents](https://onco.cc/technologies/platinum/)
- drugs: [Capecitabine](https://onco.cc/drugs/capecitabine/), [Cisplatin](https://onco.cc/drugs/cisplatin/), [Gemcitabine](https://onco.cc/drugs/gemcitabine/), [Gemcitabine + cisplatin](https://onco.cc/drugs/gemcitabine-cisplatin/)
- institutions: [Cancer Research UK](https://onco.cc/institutions/cruk/)
- terms: [Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups)](https://onco.cc/terms/gallbladder-cancer-in-biliary-trials/), [Neoadjuvant / adjuvant / perioperative](https://onco.cc/terms/neoadjuvant-adjuvant/)
- key papers: [Surgical outcomes in gallbladder cancer: evidence from the UK nationwide CAPBIL study](https://onco.cc/key-papers/paper-mcclements-capbil-surgical-outcomes-gallbladder-cancer-hpb-2026/)
- roadmaps: [Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials](https://onco.cc/roadmaps/gallbladder-cancer-roadmap/)
- ideas: [A ctDNA residual disease-guided adjuvant trial after gallbladder cancer resection](https://onco.cc/ideas/idea-gbc-ctdna-residual-disease-guided-adjuvant-trial/), [Report gallbladder cancer as its own population in every biliary trial](https://onco.cc/ideas/idea-gbc-report-gallbladder-separately-in-biliary-trials/)

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