Using Bethanechol with Chemotherapy for Pancreatic Cancer Treatment
Official title: Phase II, Neoadjuvant Study of Parasympathetic Stimulation With Bethanechol in Combination With Gemcitabine and Nab-paclitaxel in Borderline Resectable Pancreatic Adenocarcinoma
Run by Columbia University · NCT05241249 · Data updated 2026-11-12
This study is testing if adding bethanechol to chemotherapy can help people with pancreatic cancer have better surgery outcomes and if it's safe to use.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 37 (estimated) |
| Sponsor | Columbia University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | February 1, 2022 |
| Main results expected | January 2026 |
| Study ends | January 2026 |
| Registry record updated | June 5, 2025 |
| Trial ID | NCT05241249 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients diagnosed with pancreatic ductal adenocarcinoma who are planning to undergo neoadjuvant chemotherapy.
✕Probably not a fit
Patients with metastatic disease or significant comorbidities that contraindicate participation may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effects of bethanechol when combined with the chemotherapy drugs gemcitabine and nab-paclitaxel in patients with pancreatic adenocarcinoma. The primary goal is to assess whether this combination can improve R0 resection rates, which indicates successful surgical removal of the tumor. Additionally, the study will monitor the safety and tolerability of bethanechol and explore genomic biomarkers related to parasympathetic stimulation in pancreatic cancer. The hypothesis is that bethanechol may inhibit tumor growth by altering nerve conduction within tumors.
Why it matters
Potential benefit: If successful, this approach could enhance surgical outcomes and reduce the likelihood of cancer recurrence in pancreatic cancer patients.
How similar studies have gone: While the use of bethanechol in this context is experimental, previous studies have shown promising results in animal models regarding its potential to inhibit cancer growth.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pancreatic Ductal Adenocarcinoma * Plan for neoadjuvant chemotherapy * Available diagnostic tissue adequate for biomarker analysis * Ability to tolerate PO meds and comply with study procedures Exclusion Criteria: * Metastatic disease * Evidence of GI obstruction * Baseline bradycardia (HR\<55) or hypotension (systolic blood pressure\<90) * Use of acetylcholinesterase inhibitors * Medical conditions including: hyperthyroidism, active/symptomatic coronary artery disease, seizure disorder, peptic ulcer disease.
Where it's running
-
Columbia University Medical Center
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Susan E Bates, MD — Columbia University
- Study coordinator: Research Nurse Navigator
- Email: cancerclinicaltrials@cumc.columbia.edu
- Phone: 212-342-5162
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.