Table 1.
Summary of significant phase-III studies regarding chemotherapy for cholangiocarcinoma, in an adjuvant setting (A) and metastatic disease (M).
Study | Chemotherapy Regimen | Setting | Outcome | Reference |
---|---|---|---|---|
ESPAC-3 | 5-Fluoruracile versus gemcitabine | A | Better toxicity profile for gemcitabine | [10] |
PRODIGE12-ACCORD18 | GEMOX versus observation | A | RFS: No significant differences | [13] |
BCAT | Gemcitabine versus observation | A | No significant differences | [14] |
BILCAP | capecitabine versus observation | A | mOS: 51.1 months vs 36.4 months | [15] |
ACTICCA-1 | Capecitabine versus cisplatin/gemcitabine | A | ongoing | [16] |
AC-02 | Cisplatin/gemcitabine versus gemcitabine | M | mOS: 11.7 vs. 8.1 months | [18] |
Phase III trial | GEMOX versus GEMOX plus erlotinib | M | mPFS: no differences | [21] |
NuTide | Acelarin/cisplatin versus gemcitabine/cisplatin | M | ongoing | NCT04163900 |
ABC-06 | FOLFOX versus ASC | M | Survival rate at 6 months: 50.6% vs 35.5% | [32] |
TreeTopp | capecitabine versus capecitabin/Varlitinib | M | Ongoing | NCT03093870 |
GEMOX: Gemcitabine/oxaliplatin; FOLFOX: fluoruracile/oxaliplatin; ASC: active symptom control.