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Table 1 Eligibility criteria for the ACTICCA-1 enrollment 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

• Suspicion of or histologically/cytologically confirmed BTC (intrahepatic, hilar or distal CCA, or muscle invasive GBCA) scheduled for complete surgical resection.
• Written informed consent.
• Age >18 years.
• No prior CTx for BTC.
• No previous malignancy within three years or concomitant malignancy, except non-melanomatous skin cancer or adequately treated in situ cervical cancer.
• No severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction in the last three months, significant arrhythmia).
• Absence of psychiatric disorder precluding understanding of information of trial related topics and giving informed consent.
• No serious underlying medical conditions (judged by the investigator), that could impair the ability of the patient to participate in the trial.
• Fertile women (<1 year after last menstruation) and procreative men willing and able to use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile).
• No pregnancy or lactation.
  1. BTC biliary tract cancer, CCA cholangiocarcinoma, CTx chemotherapy, GBCA gallbladder carcinoma