Study of S-1 Plus DC-CIK for Patients With Unresectable Locally Advanced Pancreatic Cancer

Dendritic Cell/Cytokine-Induced Killer Cell Immunotherapy Combined With S-1 in Patients With Advanced Pancreatic Cancer: A Prospective Study.

The purpose of this study is to evaluate the antitumor effect and safety of clinical effectiveness S-1 plus dendritic cell activated Cytokine induced killer treatment (DC-CIK) for unresectable locally advanced pancreatic cancer.

Inclusion Criteria:

• Histologically or cytologically confirmed locally advanced, unresectable or metastatic adenocarcinoma of the pancreas not amenable to curative radiotherapy or surgery.
• Capable of oral intake
• Between 18 and 80 years old
• Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
• Karnofsky Performance Status (KPS) ≥ 70%
• Normal functions of heart, lung and bone marrow
• Adequate hematological profile： Hemoglobin ≥ 9.0 g/dL Absolute granulocyte count ≥ 1,500/mm3 Platelet count ≥ 100,000/mm3
• Adequate hepatic function Total bilirubin level≤ 3.0 times the upper limit of normal (ULN) Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN
• Adequate renal function(normal serum creatinine level)
• A life expectancy≥ 2 months
• Informed consent signed

Exclusion Criteria:

• Current enrollment in another clinical study with an investigational agent. Patients participating in surveys or observational studies are eligible to participate in this study
• Any radiotherapy or surgery within the previous 3 weeks
• Symptomatic brain metastasis not controlled by corticosteroids
• Bone marrow metastasis
• Active infection
• Serious complications
• Receiving a concomitant treatment with drugs interacting with S-1. The following drugs are prohibited because there may be an interaction with S-1: phenytoin, potassium warfarin , flucytosine, cimetidine and folinic acid.
• Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy