Perlmutter Cancer Center

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Advanced And/or Unresectable Biliary Tract Carcinoma
• Age: Between 18 years - 100 years
• Gender: Male or Female

• Other Inclusion Criteria:
  

  To be considered for this trial the following criterias must be met. 1) Has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer). 2) Have measurable disease based on RECIST 1.1, as determined by the site investigator. Lesions situated in a previously treated area by either radiotherapy, photodynamic therapy, or arterial embolization are considered measurable if progression has been demonstrated in such lesions and they meet criteria for measurable disease. 3) Participants with past or ongoing Hepatitis C Virus (HCV) infection are eligible for the study. Treated participants must have completed their treatment at least 1 month prior to starting study intervention. Untreated or incompletely treated HCV participants may initiate anti-viral therapy for HCV if liver function remains stable for at least 3 months on study intervention.
  

You may not be eligible for this study if the following are true:

• You will not be eligible for this trial if you have the following: 1) Have had previous systemic therapy for advanced (metastatic) or unresectable (locally advanced) biliary tract cancer (intra-or extra hepatic cholangiocarcinoma or gallbladder cancer). With exception of adjuvant therapy which is allowed. Adjuvant therapy should have been completed at least 6 months prior to diagnosis of advanced and/or unresectable disease. 2) Have ampullary cancer. 3) Have small cell cancer, neuroendocrine tumors, lymphoma, sarcoma and/or Mucinous cystic neoplasms.