Unmet needs in CCA — 3 of 3

Treatment options for patients with CCA are limited

The ESMO guidelines for the management of CCA include surgery, chemoradiotherapy, systemic therapy or locoregional therapy, and best supportive care12

  • Systemic chemotherapy with gemcitabine and cisplatin is the current SOC for 1L advanced/metastatic CCA12-14

According to the ESMO guidelines, there is no established 2L systemic therapy for patients with advanced disease following progression after 1L treatment12

  • The Phase 3, ABC-06 trial investigated ASC + FOLFOX (n=81) vs ASC only (n=81) in adult patients with locally advanced or metastatic BTC (including CCA, gallbladder and ampullary carcinoma) that have progressed following 1L cisplatin and gemcitabine chemotherapy15
    • Median OS was 6.2 months (95% CI, 5.4⁠–⁠7.6) in the ASC + FOLFOX group versus 5.3 months (95% CI, 4.1⁠–⁠5.8) in the ASC alone group (adjusted HR 0.69 [95% CI, 0.50⁠-⁠0.97], p=0.031). These results support the use of FOLFOX as 2L treatment for advanced BTC15

Clinical management algorithm based on ESMO guidelines12

Via MDT clinical trials where possible


Early stage
Locally advanced
Adjuvant chemoradiotherapy
Adjuvant chemotherapy
Systemic chemotherapy*
  • 1L combination chemotherapy (PS 0—1)
  • 1L gemcitabine monotherapy (PS 2)
  • 2L chemotherapy (no standard)
  • Targeted therapy (no standard)
Locoregional chemotherapy*
  • Radiotherapy
  • 90Y-radioembolisation (iCCA)
Best supportive care

*Option of salvage surgery should be considered in responding patients with initially inoperable disease;
Gemcitabine and cisplatin (category IA), other gemcitabine-based combination (category IIB).
Figure adapted from Valle JW, et al. Biliary cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2016;27 (Suppl 5):v28–v37. Copyright © 2016 European Society for Medical Oncology. Published by Elsevier Ltd.
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