A Phase 2 interventional study of Bethanechol and Gemcitabine in Pancreas Cancer, sponsored by Susan E. Bates. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-05.
Sponsored by Susan E. Bates · Phase 2, Interventional, and Other
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Among 370 studies testing gemcitabine in Pancreatic Neoplasms — 29 open to participants now, 44 under way, 5 of them phase 3. Gemcitabine · Pancreatic Neoplasms.
Among the 370 studies testing gemcitabine in Pancreatic Neoplasms, this one is the 176th largest by planned enrollment of the 353 interventional ones that give a count, is one of 4 that started in 2022, is one of 196 in phase 2, reaches primary completion later than 15 of the 43 other live ones, and was the 340th registered.
3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,005 are open to participants now.
Browse Pancreatic Neoplasms studies →29 of the 370 studies testing gemcitabine in Pancreatic Neoplasms are open now, in 12 countries. Recruiting first, the newest first:
Revolution Medicines, Inc. · Sites in United States
Ages 18+
Smartwise Sweden AB · Sites in Sweden
Ages 18+
Revolution Medicines, Inc. · Sites in United States, Australia, Austria and 13 more countries
Ages 18+
Shanghai Hengrui Pharmaceutical Co., Ltd. · Sites in China
Ages 18–75
Dartmouth-Hitchcock Medical Center · Sites in United States
Ages 18+
By country, each count listing its studies:
Gemcitabine: first FDA approval 1996 (GEMZAR). What it is approved for, and how studies give it, is on its page →
Of the 745 Pancreatic Neoplasms studies recruiting now, 478 (64%) set no upper age limit and 151 (20%) stop at 75 or younger; 40 take children under 18; 59 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
370 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 125 · Phase 2 239 · Phase 3 36 · Phase 4 2
First in 1995; this study’s year is marked. 4 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 37 is below the median of 47 across 2,932 interventional studies indexed under Pancreatic Neoplasms.
Median enrollment 37 across the 353 interventional studies. Of the 269 that completed or were terminated, 81 (30%) have results posted.
This tab as a report to print or save as PDF → With an account.
59 of 370 have an industry lead sponsor. The 10 most frequent:
Susan E. Bates is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Susan E. Bates has 2 studies filed under Pancreatic Neoplasms — fewer than ten, so there is no comparison to draw.
15 of the studies testing gemcitabine in Pancreatic Neoplasms that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06953999Phase 3AkesoA Phase III Study of Ivonescimab + Chemo With/Without AK117 in Metastatic Pancreatic Cancer | 2027-05-14 |
| NCT02340117SynerGene Therapeutics, Inc.Study of Combined SGT-53 Plus Gemcitabine/Nab-Paclitaxel for Metastatic Pancreatic Cancer | 2026-12 |
| NCT03652428University of Maryland, BaltimorePhase I Nab-Paclitaxel Plus Gemcitabine With Proton Therapy for Locally Advanced Pancreatic Cancer (LAPC) | 2026-12-31 |
| NCT04115163Anne NoonanBiologically Optimized Infusion Schedule of Gemcitabine and Nab-Paclitaxel for the Treatment of Metastatic Pancreatic Cancer | 2026-12-31 |
| NCT04894643EBG MedAustron GmbHPreoperative, Proton- Radiotherapy Combined With Chemotherapy for Borderline Resectable Pancreatic Cancer | 2026-12-31 |
Add all 15 to your calendar (.ics) → With an account.
Among the 370 studies testing gemcitabine in Pancreatic Neoplasms, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The primary objective of this study is to assess the impact of bethanechol therapy on R0 resection rates. The safety objective will be assessment of the safety and tolerability of bethanechol in combination with gemcitabine and nab-paclitaxel. The exploratory objective will be to evaluate genomic biomarkers associated with parasympathetic stimulation in pancreatic cancer, and the ability to reduce tumor growth rate.
The purpose of this study is to determine whether the drug, bethanechol, could potentially be used in combination with chemotherapy regimen gemcitabine and nab-paclitaxel and surgery to decrease the chance of the cancer coming back after it is removed. Animal models have shown that treatment with bethanechol can inhibit cancer growth and spread. The chemotherapy regimen nab-paclitaxel for use in combination with gemcitabine to treat patients with metastatic pancreatic cancer is FDA approved. Although bethanechol is FDA approved, in this study its use is experimental. The aim of the study is to show that the medication is easy to tolerate and that it shows signs of slowing cancer cell growth. The investigators hypothesize that treatment with bethanechol will alter nerve conduction within tumors by stimulating the parasympathetic nervous system and reduce tumor proliferation, decrease CD44+ expression in cancer cells, decrease tumor growth rate resulting in an improved R0 resection rate.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with borderline resectable pancreatic cancer and no contraindication to bethanechol therapy will receive bethanechol on day 1 and continue until 2 days prior to scheduled surgery for a minimum of 2 months.
Drug: Bethanechol · Drug: Gemcitabine · Drug: nab-paclitaxel
Study Drug: Bethanechol (generic), supplied as 50mg oral tablets. Subjects will take 2 tablets (100mg) twice daily. Medication should be taken 1 hour before meals in AM and PM. Medication will be purchased commercially and dispensed at the research pharmacy.
Also known as: Bethanechol chloride tablet
Non-experimental. Chemotherapy will be administered on a day 1, 8 and 15 schedule with gemcitabine at a dose of 1000 mg/m2
Non-experimental. Chemotherapy will be administered on a day 1, 8 and 15 schedule with nab-paclitaxel dose at 125 mg/m2
R0 resection rate
This rate will be analyzed in patients treated with bethanechol in combination with gemcitabine and nab-paclitaxel compared to historical R0 resection rates.
Time frame: 36 months
Ki-67 expression in tumor cells
This is to measure cell proliferation by Ki-67 expression in tumor cells, to quantify the change in tumor growth and alterations in inflammatory cytokines and immune profiles.
Time frame: 36 months
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2022 (actual). Primary completion is estimated for Jan 2026, 47 months after the start.
Of 324 non-industry phase 2 interventional studies under Pancreatic Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 80. This study's planned 47 months is below that.
Counting every sponsor, half of 393 studies reached it within 57 months; a quarter within 35 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Bethanechol · Gemcitabine · Albumin-Bound Paclitaxel
Susan E. Bates