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Table 2 Selection criteria for the ACTICCA-1 treatment phase

From: Adjuvant chemotherapy with gemcitabine and cisplatin compared to observation after curative intent resection of cholangiocarcinoma and muscle invasive gallbladder carcinoma (ACTICCA-1 trial) - a randomized, multidisciplinary, multinational phase III trial

• Histologically confirmed BTC (intrahepatic, hilar or distal CCA, or muscle invasive GBCA) after surgical therapy with macroscopically complete resection (mixed tumor entities with hepatocellular carcinoma are excluded).
• Macroscopically complete resection (R0/1) within 6 (−16) weeks before scheduled start of CTx.
• Performance status according to the ECOG of 0–1.
• Adequate hematologic function: ANC ≥1.5 × 109/L, platelets ≥100 × 109/L, hemoglobin ≥9 g/dl or ≥5.59 mmol/L.
• Adequate liver function as measured by serum transaminases (AST and ALT) ≤5 x ULN and bilirubin ≤3 x ULN.
• Adequate renal function, i.e. serum creatinine ≤1.5 x ULN, glomerular filtration rate ≥ 60 mL/min determined with the MDRD formula.
• No active uncontrolled infection, except chronic viral hepatitis under antiviral therapy.
• No concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment in a clinical trial within 30 days prior to randomization.
• Negative serum pregnancy test within 7 days of starting study treatment in pre-menopausal women and women <1 year after the onset of menopause (a negative test has to be reconfirmed by a urine test, should the 7-day window be exceeded).
  1. ANC absolute neutrophil count, BTC biliary tract cancer, CCA cholangiocarcinoma, CTx chemotherapy, ECOG Eastern Cooperative Oncology Group, GBCA gallbladder carcinoma, MDRD Modification of Diet and Renal Disease, ULN upper limit of normal