NCT04276857 Systemic Therapy With a Loco-regional Treatment in Patients With Locally Advanced Pancreatic Cancer
| NCT ID | NCT04276857 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Saskatchewan |
| Condition | Locally Advanced Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 27 participants in total. It began in 2025-05-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background Pancreatic cancer is one the leading causes of cancer-related death in Canada. Approximately 40 percent of patients with pancreatic cancer present with locally advanced pancreatic cancer and are not candidate for curative surgery. The optimal management of patients with locally advanced pancreatic cancer remains unknown. Most patients are treated with chemotherapy alone and role of local treatment such as radiation is not well defined. Other conventional ablative therapies such as thermal ablation and cryoablation have limited role in locally advanced pancreatic cancer due to the risk of collateral damage to the adjacent structures. Irreversible electroporation (IRE) is a novel non-thermal ablation technology that does not cause injury to nearby blood vessels, ducts, and bowel and has potential to provide longer disease control and thereby a better overall survival. The current study aims to prospectively validate effectiveness and safety of IRE in real-world patients with locally advanced pancreatic cancer. Objectives 1\) To determine 12-month progression-free survival (PFS) and 24-month overall survival rates of patients with locally advanced pancreatic cancer who are treated with combination chemotherapy and IRE and 2) to compare progression-free and overall survival of patients with locally advanced pancreatic cancer who are treated with combination chemotherapy and IRE versus combination chemotherapy alone. Design Prospective multicenter single arm study. Methods Based on the assumption of doubling of PFS of patients who are being treated with IRE and chemotherapy versus chemotherapy alone we estimated a sample of n=27 of adult patients with histologically proven non-metastatic locally advanced adenocarcinomas. Eligible patients will be recruited at the two major cancer centers in Saskatchewan. All IRE eligible patients will receive 12 weeks of induction chemotherapy and will undergo repeat imaging studies. If there is no disease progression IRE will be performed. An additional 12 weeks of chemotherapy will be recommended. Patients who are not eligible for IRE due to size criteria will receive chemotherapy at the discretion of treating oncologist till disease progression or till they become eligible for IRE. Quality of life will be assessed every three months or until disease progression. Significance Despite progress in the management of most solid organ cancers and better outcomes, little advancement has been made in the treatment of patients with locally advanced pancreatic cancer. Unfortunately, most patients have very limited life expectancy. There is an unmet need for novel approaches in the management of patients with locally advanced pancreatic cancer. IRE in combination with chemotherapy has potential to improve local disease control and thereby improves survival and may prove a valuable tool to add in the multidisciplinary treatment of cancer. The result of this study will be used for the development of a future multicenter national phase III trials.
Eligibility Criteria
Inclusion Criteria: Adult patients with biopsy-proven locally advanced pancreatic adenocarcinoma who are candidates for combination chemotherapy as determined by treating oncologists. Exclusion Criteria: 1. Pregnancy 2. Metastatic pancreatic cancer 3. Another active second primary cancer with the exception of squamous cell carcinoma of the skin or an in situ cancer.
Contact & Investigator
Shahid Ahmed, MD, PhD
PRINCIPAL INVESTIGATOR
University of Saskatchewan
Frequently Asked Questions
Who can join the NCT04276857 clinical trial?
This trial is open to participants of all sexes, studying Locally Advanced Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04276857 currently recruiting?
Yes, NCT04276857 is actively recruiting participants. Contact the research team at shahid.ahmed@saskcancer.ca for enrollment information.
Where is the NCT04276857 trial being conducted?
This trial is being conducted at Regina, Canada, Saskatoon, Canada.
Who is sponsoring the NCT04276857 clinical trial?
NCT04276857 is sponsored by University of Saskatchewan. The principal investigator is Shahid Ahmed, MD, PhD at University of Saskatchewan. The trial plans to enroll 27 participants.
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