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. 2019 Oct;10(5):944–956. doi: 10.21037/jgo.2019.05.10

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