Table 1. Study inclusion and exclusion criteria.
Inclusion criteria | Exclusion criteria |
---|---|
Predominant hepatic disease: unresectable intrahepatic cholangiocarcinoma or hepatic tumor of liver from pancreatic adenocarcinoma | Inadequate hepatic function defined by aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ratio of more than five times higher than normal limit, bilirubin >2.0 mg/dL or history of hepatic encephalopathy |
Limited extra hepatic metastasis as: (I) six or less nodules with no nodule greater than 1.5 cm in lungs; (II) abdominal lymph nodes; (III) pancreatic primary as long as the size is less than 4 cm in size; (IV) bone metastasis |
Inadequate renal function considered by creatinine level of >2.0 mg/dL |
Measurable target tumors using standard imaging techniques | Inadequate bone marrow function by detecting platelets <100,000/mL or absolute neutrophil count <1,500/mL |
No hepatic cirrhosis | Persistent grade 2 or more non-hematologic toxicity, except for alopecia |
Eastern Cooperative Oncology Group (ECOG) performance score 0–1 | Contraindication to angiography |
No prior systemic therapy for advanced stage disease | Prior external beam radiotherapy to the upper abdomen |
No other investigational agents while on protocol | Clinical evidence of peritoneal metastasis or ascites |
Less than 20% lung shunting fraction (LSF) | Patients with extensive tumor replacement in the liver defined as >50% of liver involved with tumor |
Any serious ongoing extra-hepatic disease such as infections | |
Disease progression at any time from starting of therapy | |
Institution of any anti-cancer therapy other than the current protocol. Patients undergoing surgery for palliation without evidence of disease progression will stay on the study | |
Unacceptable toxicity including: delay in treatment for ≥4 weeks and requirement of more than 2 dose reductions for gemcitabine |