Clinical trial · Interventional
Immunochemoradiotherapy in Patients With Pancreatic Cancer
Exploratory Trial of Immunochemoradiotherapy for Locally Advanced Pancreatic Adenocarcinoma
NCT01342224CI-TRIAL-00032497completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will add an immunotherapy component to chemotherapy and radiation treatment in patients who have pancreatic cancer. The objective of this study is to see if the combined treatment is safe and feasible, and if a larger study is warranted.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tadalafil and vaccination | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- tadalafil and vaccination
- description
- Participants receive a 4-week course of vaccination with telomerase vaccine and GM-CSF by injection, along with a cycle of gemcitabine chemotherapy (IV). This is followed by radiation and gemcitabine given twice weekly then by another dose of vaccine.
- interventionNames
- Biological: tadalafil and vaccination
Primary outcomes (1)
- measure
- Safety
- timeFrame
- 180 Days
- description
- Adverse events will be graded no less than weekly for the first 180 days. Post-treatment long-term follow-up will occur every 12 weeks beyond day 180 for 6 visits and then every 24 weeks thereafter until progressive disease, withdrawal from study or death. For this pilot study, adverse events and efficacy measures will be personally reviewed by the principal investigator. Both hematologic and non-hematologic toxicity will be anticipated. In conjunction with the IRB, stopping the trial will be among possible measures taken if undue toxicity or inadequate outcomes are observed.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDCrocenzi T, Cottam B, Newell P, Wolf RF, Hansen PD, Hammill C, Solhjem MC, To YY, Greathouse A, Tormoen G, Jutric Z, Young K, Bahjat KS, Gough MJ, Crittenden MR. A hypofractionated radiation regimen avoids the lymphopenia associated with neoadjuvant chemoradiation therapy of borderline resectable and locally advanced pancreatic adenocarcinoma. J Immunother Cancer. 2016 Aug 16;4:45. doi: 10.1186/s40425-016-0149-6. eCollection 2016. PMID 27532020