ABC-08: Phase Ib Trial of Acelarin in Combination With Cisplatin in Locally Advanced/ Metastatic Biliary Tract Cancers

Inclusion Criteria: * Histologically/cytologically verified, non-resectable or recurrent/metastatic cholangiocarcinoma, gallbladder or ampullary carcinoma. * No prior systemic therapy allowed for advanced biliary cancer. Prior low dose chemotherapy used with or without radiotherapy in the adjuvant setting is allowed if completed \> 6 months from enrolment. Recent palliative radiation (within 28 days prior to consent) is allowed if candidate has measurable disease outside radiation field. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Age ≥ 18 years and life expectancy \> 3 months. * Adequate renal function with serum urea and serum creatinine \< 1.5 times upper limit of normal (ULN) and creatinine clearance ≥ 30ml/min. * Adequate haematological function: Hb ≥ 10g/dl, white blood count (WBC) ≥ 3.0 x 10\*9/L, absolute neutrophil count (ANC) ≥ 1.5 x 10\*9/L, platelet count ≥ 100,000/mm3. * Adequate liver function: total bilirubin \< 30 μmol/L and alkaline phosphatase, along with aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 5 x ULN. * Adequate biliary drainage, with no evidence of ongoing infection. * Women of child bearing age MUST have a negative pregnancy test prior to study entry AND be using a highly effective contraception method (combined or progestogen-only hormonal contraception, intrauterine device, intrauterine hormone-releasing system, vasectomised partner\*(a) or sexual abstinence\*\*(b)) which must be continued for…