Clinical trial · Interventional
Chemoimmunotherapy and Radiation in Pancreatic Cancer
Phase I Trial of Chemoimmunotherapy and Hypofractionated Radiation Therapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma.
NCT01903083CI-TRIAL-00031490CRITcompletedPhase 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)
The goal of this study is to evaluate the safety of combination treatment that includes chemotherapy, radiation therapy, and immunotherapy in patients with pancreatic cancer.
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 Malignant Neoplasm | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Pancreaticoduodenectomy | Procedure | — | UNRESOLVED |
| Radiation | Radiation | — | UNRESOLVED |
| Tadalafil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Immunochemoradiotherapy
- description
- Immunotherapy with oral tadalafil daily; three doses of chemotherapy with IV Gemcitabine in 21-day cycles for up to 4 cycles; three fractions of external beam radiation to the pancreas and and regional lymph nodes; pancreaticoduodenectomy (surgical resection) for eligible patients.
- interventionNames
- Drug: Tadalafil
- Drug: Gemcitabine
- Radiation: Radiation
- Procedure: Pancreaticoduodenectomy
Primary outcomes (1)
- measure
- Safety
- timeFrame
- 135 Days
- description
- Patients will return be seen in the clinic 8 times over the first 50 days for an evaluation of adverse events and toxicities before being evaluated for surgery. Patients who are not candidates for surgery will be seen in clinic 10 more times over the next 85 days for safety evaluations, and patients who have surgery will be seen 10 times over the 85 days following recovery from surgery for safety evaluations.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pancreatic adenocarcinoma * Locally advanced unresectable disease, or borderline resectable disease * ECOG (Eastern Cooperative Oncology Group)Performance Status 0 or 1 * Ability to provide consent and comply with study protocol * Women of child-bearing potential must have a negative pregnancy test and avoid pregnancy during the study Exclusion Criteria: * Age \< 18 * History of other malignancy in previous 2 years except carcinoma in situ of the cervix or bladder, or non-melanoma skin cancer * Previous chemotherapy or radiation therapy for pancreatic cancer or previous radiation to the target field * Clinically active autoimmune disease or active infection * History of heart attack within 90 days or stroke within 6 months, hypertension requiring change in blood pressure medications in the last 4 weeks, hypotension, uncontrolled arrhythmias, heart failure (NYHA \>= Class 2 in last 6 months), unstable angina, or angina 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 * Use of recreational drugs called 'poppers' like amyl nitrite and butyl nitrite * Blood test results (neutrophils \< 1000 /uL (microliter); hemoglobin \< 9 gm /dL; platelet count \< 1000 cells / uL; significant coagulopathy; significant liver or renal dysfunction
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