# ABC-06

Source: https://onco.cc/trials/abc-06/  
OnCo record `abc-06` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

ABC-06 was the first randomised trial to show that a second round of chemotherapy, FOLFOX, helps people with bile duct and gallbladder cancer live somewhat longer once gemcitabine and cisplatin have stopped working.

## Summary

The UK ABC-06 trial randomised 162 patients with locally advanced or metastatic biliary tract cancer (cholangiocarcinoma, gallbladder or ampullary cancer) whose disease had progressed on first-line gemcitabine and cisplatin to active symptom control alone or with modified FOLFOX (oxaliplatin, folinic acid and fluorouracil). The primary endpoint was overall survival.

FOLFOX produced a modest but significant improvement in overall survival with acceptable toxicity, and gave biliary cancer its first evidence-based second-line chemotherapy. Targeted drugs for FGFR2 and IDH1 alterations and the NIFTY trial of liposomal irinotecan have since added other options.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-17
- Tags: subtype-trials
- Registry id: NCT01926236
- Phase: 3
- Setting: Advanced biliary tract cancer after progression on gemcitabine and cisplatin: active symptom control with or without modified FOLFOX
- Sponsor: The Christie NHS Foundation Trust
- Enrolled: 162
- Result: Modified FOLFOX plus active symptom control modestly improved overall survival over active symptom control alone.
- Outcomes: Overall survival: Active symptom control + FOLFOX 6.2 months vs Active symptom control alone 5.3 months, HR 0.69; Overall survival at 12 months: Active symptom control + FOLFOX 25.9% vs Active symptom control alone 11.4%; Overall survival at 6 months: Active symptom control + FOLFOX 50.6% vs Active symptom control alone 35.5%; Grade 3-5 adverse events: Active symptom control + FOLFOX 69% vs Active symptom control alone 52%

## Notes

- Gallbladder cancer: eligibility was histologically or cytologically verified non-resectable or recurrent or metastatic cholangiocarcinoma, gallbladder or ampullary carcinoma after progression on cisplatin and gemcitabine (registry conditions: biliary tract cancer, gallbladder cancer, cholangiocarcinoma, ampullary cancer); the gallbladder share and a gallbladder-specific hazard ratio are not in the abstract. FOLFOX after gemcitabine and cisplatin is the NHS second-line standard that NICE used as the comparator for ivosidenib (TA948), pemigatinib (TA722) and zanidatamab (TA1153).
- UK sites (17, registry): Queen Elizabeth Hospital Birmingham; Bristol Haematology and Oncology Centre; North Cumbria (Carlisle); Beatson (Glasgow); Castle Hill (Hull); St James's (Leeds); Clatterbridge (Liverpool); Guy's and St Thomas', Hammersmith, Royal Free and University College London (London); Maidstone Hospital; The Christie (Manchester); Nottingham City Hospital; Churchill (Oxford); Weston Park (Sheffield).

## Sources

- ClinicalTrials.gov NCT01926236: https://clinicaltrials.gov/study/NCT01926236
- Lamarca et al., Lancet Oncology 2021: ABC-06: https://doi.org/10.1016/S1470-2045(21)00027-9

## Connected records

- 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: [Fluorouracil (5-FU)](https://onco.cc/drugs/fluorouracil/), [FOLFOX (5-FU, leucovorin, oxaliplatin)](https://onco.cc/drugs/folfox/), [Leucovorin (folinic acid)](https://onco.cc/drugs/leucovorin/), [Oxaliplatin](https://onco.cc/drugs/oxaliplatin/)
- terms: [Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups)](https://onco.cc/terms/gallbladder-cancer-in-biliary-trials/)
- people: [Angela Lamarca](https://onco.cc/people/angela-lamarca/), [John Bridgewater](https://onco.cc/people/john-bridgewater/), [Juan W. Valle](https://onco.cc/people/juan-valle/), [Mairéad McNamara](https://onco.cc/people/mairead-mcnamara/)
- key papers: [Second-line FOLFOX chemotherapy versus active symptom control for advanced biliary tract cancer (ABC-06): a phase 3, open-label, randomised, controlled trial](https://onco.cc/key-papers/paper-abc-06-folfox-second-line-lancet-oncol-2021/)
- trials: [NIFTY](https://onco.cc/trials/nifty/)
- 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: [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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