Immunochemoradiotherapy in Patients With Pancreatic Cancer

This is an interventional other trial for Locally Advanced Pancreatic Adenocarcinoma focused on measuring pancreatic, cancer, adenocarcinoma, vaccine Read More

Inclusion Criteria:

Pancreatic adenocarcinoma proven by biopsy or cytology Locally advanced, unresectable disease with absence of distant metastatic disease. The presence of non-regional retroperitoneal or abdominal adenopathy is acceptable for inclusion.

OR

Borderline resectable pancreatic adenocarcinoma (any of the following):

• Tumor abutment or encasement of a short segment of hepatic artery (without evidence of tumor extension to the celiac artery) that is amenable to resection and reconstruction
• Tumor abutment of the superior mesenteric artery involving 180 degrees or less of the circumference of the artery and without encasement
• Impingement or narrowing of the superior mesenteric vein/portal vein or short-segment (< 2 cm) occlusion of the superior mesenteric vein, portal vein, or their confluence with a suitable option for vascular reconstruction
• Eastern Cooperative Oncology Group(ECOG)Performance Status 0 or 1
• Ability to give informed consent and comply with the protocol
• Women of childbearing potential must have a negative pregnancy test and must avoid becoming pregnant while on treatment. Men must avoid fathering a child while on treatment.
• Patients with a history of psychiatric illness must be judged able to understand fully the investigational nature of the study and the risks associated with the therapy.

Exclusion Criteria:

• Age < 18 years
• History of other malignancy in the past 2 years except carcinoma in situ of the cervix or bladder, or non-melanomatous skin cancer
• Previous chemotherapy or radiation therapy for pancreatic cancer or previous radiation therapy to the target field
• Clinically active autoimmune disease or active infection
• History of heart attack (within 90 days) or stroke (within 6 months), or presence of hypertension requiring change in blood pressure medications in the last 4 weeks, hypotension, uncontrolled arrhythmias, heart failure (New York Heart Association (NYHA) Functional Classification ≥ Class 2 in last 6 months), unstable angina or angina occurring during sexual activity.
• Use of "nitrates" or nitroglycerin.
• History of hereditary degenerative retinal disorders including retinitis pigmentosa.
• Chronic systemic corticosteroid use at supra-physiologic doses (prednisone > 10 mg a day or equivalent)
• Use of recreational drugs called "poppers" like amyl nitrite and butyl nitrite.

• Laboratory values (performed within 14 days prior to enrollment) as follows:

  • Neutrophil count < 1500 cells/µL
  • Hemoglobin < 9 gm/dL (patients may be transfused to establish eligibility)
  • Platelet count < 100,000 cells/µL
  • Significant coagulopathy (INR > 1.5)
  • Significant liver or renal dysfunction
• Other medical or psychiatric conditions that in the opinion of the Principal Investigator would preclude safe participation in protocol.