Second-Line Oxaliplatin and Irinotecan Versus Irinotecan Alone for Gemcitabine and S-1 Refractory Pancreatic Cancer

Second-Line Oxaliplatin and Irinotecan Versus Irinotecan Alone for Advanced Pancreatic Cancer Patients Progressed After First-line Gemcitabine and S-1: A Randomized Controlled Study

This study is a randomized, open-label, controlled study that will compare the efficacy of oxaliplatin in combination with irinotecan to irinotecan alone as second-line treatment for patients with gemcitabine and S-1 refractory pancreatic cancer.

Inclusion Criteria:

• Patients with histologically confirmed advanced pancreatic cancer who had experienced progression during first-line gemcitabine and S-1 were eligible for enrollment on this open-label, randomized study.
• Additional inclusion criteria were age 18 years or older
• Measurable reference cancer site(s) confirmed with computed tomography (CT) or magnetic resonance imaging (MRI)
• Karnofsky performance status (KPS) of at least 70%
• -Adequate renal function, adequate hepatic function, adequate bone marrow function

Exclusion Criteria:

• The presence of any severe concomitant disease that could interrupt the planned treatment; intractable pain
• Hypersensitivity to study drugs
• Serious cardiovascular disease (eg, unstable coronary artery disease or myocardial infarction within 4 weeks of study start)
• National Cancer Institute CommonToxicity Criteria grade 3 or 4 sensory or motor neuropathy
• Prior or concurrent malignancy (other than pancreatic cancer)
• Female, pregnancy or breastfeeding.