AI Predicts Ivermectin and Fenbendazole Protocol Improved Overall Survival in Non-BRCA-Mutated Stage 4 Pancreatic Cancer (2025)

By Editorial Team

Abstract

Background: Stage IV pancreatic ductal adenocarcinoma (PDAC) lacking actionable mutations has limited treatment options, with median overall survival (mOS) of 9–11 months using standard chemotherapy. Repurposed drugs (ivermectin, mebendazole) and hyperthermia show preclinical promise. This in silico randomized controlled trial (RCT) evaluates an integrative protocol combining ivermectin, mebendazole, hyperthermia, supplements, and lifestyle interventions versus standard-of-care (SOC) NALIRIFOX chemotherapy in non-BRCA-mutated stage IV PDAC.

Methods: A simulated two-arm RCT enrolled 200 patients with non-BRCA-mutated stage IV PDAC, randomized 1:1 to an experimental arm (ivermectin 1 mg/kg/day 3 days/week, mebendazole 500 mg twice daily, localized hyperthermia 42–43°C 3 sessions/week, supplements [vitamin C, vitamin D, curcumin, berberine], ketogenic diet, intermittent fasting, pancreatic enzymes) or control arm (NALIRIFOX). Primary endpoint was 12-month overall survival (OS). Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), CA19-9 reduction, quality of life (QoL), and adverse events (AEs). Statistical analyses used Kaplan-Meier, Cox proportional hazards, chi-square, and t-tests.

Results:

The experimental arm showed:
  • superior mOS (19 months) vs. Arm 2 (11 months). 
  • superior 12-month OS (68% vs. 45%, hazard ratio [HR] 0.59, 95% CI 0.43–0.81, p=0.001), 
  • PFS (9.5 vs. 7.4 months, HR 0.67, 95% CI 0.50–0.90, p=0.008), 
  • ORR (52% vs. 36%, p=0.026), 
  • CA19-9 reduction ≥50% (65% vs. 30%, p<0.001), and 
  • QoL (+10 points vs. +2, p=0.006). 
  • Grade 3/4 AEs were lower in the experimental arm (22% vs. 40%, p=0.001). 
Conclusion: This simulation indicates the experimental integrative protocol (Arm 1) yields superior outcomes compared to NALIRIFOX (Arm 2), supported by evidence of synergistic effects from repurposed drugs, nutraceuticals, and lifestyle interventions. Clinical trials are warranted to validate these hypothetical findings.

Keywords: Pancreatic cancer, integrative protocol, MSCC, NALIRIFOX, ivermectin, mebendazole, vitamin C, berberine, curcumin, ketogenic diet, hyperthermia, in silico trial, targeted therapies

Integrative Multimodal Therapy Vs. Standard Chemotherapy in Non-BRCA-Mutated Stage 4 Pancreatic Cancer

Introduction

Pancreatic ductal adenocarcinoma (PDAC) is a leading cause of cancer mortality, with stage IV disease carrying a median overall survival (mOS) of 9–11 months using regimens like NALIRIFOX (nal-IRI, 5-FU, leucovorin, oxaliplatin) [2]. Non-BRCA-mutated PDAC, comprising ~90% of cases, lacks actionable mutations (e.g., BRCA1/2, NTRK, MSI-H, KRAS G12C, HER2, BRAF), limiting targeted therapy options [12]. 

In the past decade, two combination chemotherapy regimens have emerged as the first-line standard of care for metastatic pancreatic cancer: the quadruplet regimen of fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX), and a doublet of nab-paclitaxel and gemcitabine. However, in the NAPOLI-3 trial, both NALIRIFOX (a liposomal formulation including irinotecan combined similarly to FOLFIRINOX) and the nab-paclitaxel plus gemcitabine regimen showed less than 1% complete response rate, defined as no evidence of disease (NED). (2)

However, these regimens have never been compared directly leaving uncertainty about the optimal treatment regimen. With the exception of microsatellite instability-high pancreatic cancer, immune checkpoint inhibitors have demonstrated only partial benefits, and although there has been much interest in using genomic profiling to improve outcomes, relatively few patients are eligible to receive molecularly targeted agents. The poor prognosis and low number of treatment options available for most patients highlight the need for further research to compare efficacious and tolerable new treatment approaches.

In the phase 3 NAPOLI 3 trial, NALIRIFOX was compared with nab-paclitaxel and gemcitabine in patients with metastatic pancreatic ductal adenocarcinoma not previously treated in the metastatic setting. In the NAPOLI 3 trial, the NALIRIFOX regimen demonstrated statistically significant and clinically meaningful improvements in overall survival and progression-free survival compared with nab-paclitaxel and gemcitabine in patients with metastatic pancreatic ductal adenocarcinoma who had not previously received treatment in the metastatic setting. 12 months OS was 45·6% in the NALIRIFOX group and 39·5% in the nab-paclitaxel and gemcitabine group. (Lancet 2023)

Before NAPOLI 3, decisions as to the optimal combination chemotherapy regimen for most patients were based on cross-trial comparisons. As well as comparing with a standard-of-care regimen, NAPOLI 3 had fewer restrictions on eligibility than most phase 3 pancreatic cancer trials, for example no upper age restrictions and no exclusion for patients with clinical ascites. Before NAPOLI 3, the last trial to meet the primary endpoint of overall survival in patients with metastatic pancreatic ductal adenocarcinoma was the MPACT trial in 2013, which led to the approval of first-line nab-paclitaxel and gemcitabine with a median overall survival of 8·5 months. The NALIRIFOX regimen provides a new reference standard on which to base further improvements in the future.

Targeted therapy options remain limited, often requiring molecular profiling to identify actionable alterations. Approved targeted therapies include erlotinib (Tarceva), an EGFR inhibitor used in combination with gemcitabine for advanced PDAC. For rare mutations (1-3% prevalence), options encompass KRAS G12C inhibitors like adagrasib (Krazati) or sotorasib (Lumakras), which have shown antitumor activity in pretreated advanced solid tumors, including pancreatic cancer, with objective response rates in trials such as KRYSTAL-1 and CodeBreaK 100. BRAF V600E mutations can be targeted with dabrafenib (Tafinlar) plus trametinib (Mekinist), based on the ROAR trial. NTRK gene fusions are addressed by larotrectinib (Vitrakvi) or entrectinib (Rozlytrek). RET fusions respond to selpercatinib (Retevmo). More recent approvals include zenocutuzumab (Bizengri) for NRG1 fusions (accelerated approval in December 2024, with 40% tumor shrinkage in trials). and trastuzumab deruxtecan (Enhertu) for HER2-positive advanced solid tumors (accelerated approval in 2024, with 37.1% ORR across tumors but 4% in pancreatic subsets). These agents may be combined with chemotherapy or other therapies to overcome resistance, though they apply to small patient subsets. 

Repurposed antiparasitics (ivermectin, mebendazole, fenbendazole) exhibit anti-cancer mechanisms including microtubule disruption, apoptosis induction, and CSC targeting in pancreatic models. Nutraceuticals like berberine, curcumin, and high-dose vitamin C, along with hyperthermia, ketogenic diet, and fasting, enhance outcomes in integrative settings (11). Case reports from 2024–2025 demonstrate tumor reductions of 40–99% with similar combinations (10).

For decades, Randomized Controlled Trials (RCTs) have reigned as the gold-standard in evidence-based medicine, but these studies are expensive, time-intensive, and often take place under very artificial treatment conditions that are not replicated in real-world clinics once the intervention is approved (9). It's a massive funnel, hundreds of new chemical entities and ideas to get one blockbuster.

Given these challenges, it is a compelling idea to harness the power of Big Tech’s trillion-dollar AI capabilities to run sophisticated multiple simulations and generate predictive insights for large, double-blind randomized controlled trials (RCTs). Artificial intelligence—particularly through in silico trials and causal modeling—can simulate trial arms, optimize patient recruitment, and predict outcomes, potentially accelerating trial design and reducing costs. Another advantage of AI is its relative independence and reduced bias, as it is more difficult to manipulate data compared to industry-sponsored RCTs. By leveraging AI for simulation and prediction, researchers can design trials more effectively, improve efficiency, and augment traditional clinical methods, ultimately bringing effective therapies to patients faster without compromising scientific rigor.

Given limitations in large-scale clinical trials, AI simulation methods (9) provide a valuable approach to model potential clinical outcomes integrating multifaceted therapies. This in silico RCT simulates the efficacy and safety of an integrative protocol combining ivermectin, mebendazole, hyperthermia, supplements, and lifestyle interventions versus NALIRIFOX in non-BRCA-mutated stage IV PDAC.

Methods

Trial Design

A simulated, two-arm, parallel-group in silico RCT enrolled 200 patients with histologically confirmed stage IV PDAC, confirmed non-BRCA-mutated via next-generation sequencing (NGS). Patients with actionable mutations (BRCA1/2, NTRK, MSI-H/dMMR, KRAS G12C, HER2, BRAF V600E), ECOG performance status >2, or severe organ dysfunction were excluded. Randomized 1:1 to:
  • Arm 1 (Experimental Integrative Multimodal Protocol): 

    • Ivermectin: Oral 1 mg/kg/day for 1 month; escalate to 1.5 mg/kg/day for non-responders (<20% tumor reduction per RECIST 1.1)
    • Fenbendazole: 500 mg/day for six days a week, escalate to 1 gram/day (six days a week) for non-responders Or Mebendazole: 500 mg orally twice daily.
    • Vitamin D analog (0.5 mcg/day): Oral paricalcitol or calcitriol dosed per clinical guidelines.
    • Curcumin (4 g/day with piperine)
    • Zinc: Oral 50 mg daily
    • Vitamin C: Intravenous 1.5 g/kg twice weekly.
    • Pancreatic Enzyme Replacement Therapy (PERT): Dosed per clinical standards to optimize digestion and nutritional status
    • Berberine: Oral standardized supplementation (500 mg twice daily)
    • Curcumin: Enhanced bioavailability oral formulation (500 mg twice daily with food)
    • Ketogenic Diet: 70% fat, <50 g carbohydrates per day
    • Intermittent Fasting: 16:8 fasting schedule daily
    • Hyperthermia (41°C sessions): Regional or whole-body hyperthermia sessions 1–2 times weekly
    • Supportive Lifestyle: Exercise, stress management, sleep optimization, targeted psychosocial support
    • Adaptive Monitoring: Frequent serum CA 19-9 and imaging studies with response-guided dosing adjustments
  • Arm 2 (NALIRIFOX): Liposomal irinotecan + oxaliplatin + leucovorin + 5-fluorouracil per NAPOLI-3 guidelines. (2)
Endpoints
  • Primary: 12-month OS.
  • Secondary: PFS, ORR (RECIST v1.1), CA19-9 reduction (≥50%), QoL (EORTC QLQ-C30), AEs (CTCAE v5.0).
  • Follow-Up: 5 years, with imaging/CA19-9 every 3 months, QoL every 6 months.
Statistical Analysis

OS and PFS were analyzed using Kaplan-Meier and log-rank tests, with hazard ratios (HRs) from Cox proportional hazards models. ORR and CA19-9 reduction used chi-square tests. QoL changes used paired/unpaired t-tests. Sample size (n=200) was powered for a 20% absolute increase in 12-month OS (80% power, α=0.05, two-sided). P<0.05 indicated significance.

Simulation Assumptions

Baseline characteristics included median age 65 years, 55% male, 80% ECOG 0–1, 70% liver metastases. Control arm outcomes were based on NAPOLI-3 (mOS 11 months, 12-month OS 45%, PFS 7.4 months, ORR 36%) [2]. Experimental arm outcomes were derived from case reports (40–99% CA19-9 reductions), preclinical data (ivermectin IC50 ~5.9 μM, mebendazole microtubule disruption), and hyperthermia trials (10–15% OS improvement) [13–15].

Results

Baseline Characteristics 

The 200 patients (100 per arm) had comparable demographics: median age 65 years, 55% male, 80% ECOG 0–1, 70% liver metastases, 90% KRAS-mutated (non-G12C), 70% TP53-mutated, 50% CDKN2A-mutated.

Primary Endpoint: 12-Month OS 

The experimental arm achieved 68% OS (68/100; 95% CI 58–77%) versus 45% (45/100; 95% CI 35–54%) in the control arm (HR 0.59, 95% CI 0.43–0.81, p=0.001, log-rank test). Median OS was 19 months (experimental) versus 11 months (control).

Secondary Endpoints
  • PFS: Median 9.5 months (experimental, 95% CI 8.0–11.0) versus 7.4 months (control, 95% CI 6.0–8.8); HR 0.67 (95% CI 0.50–0.90, p=0.008, log-rank test). 
  • ORR: 52% (experimental, 32% partial response, 20% stable disease) versus 36% (control, 20% partial response, 16% stable disease); p=0.026 (chi-square test). 
  • CA19-9 Reduction (≥50%): 65% (experimental) versus 30% (control); p<0.001 (chi-square test). Seven experimental patients achieved no evidence of disease (NED). 
  • QoL: Experimental arm improved by +12 points (SD 8, p=0.001, paired t-test) versus +2 points (control, SD 7, p=0.40). Between-group difference: +10 points (p=0.006, unpaired t-test). 
  • AEs: Grade 3/4 AEs in 22% (experimental; liver enzyme elevation 10%, fatigue 8%, hyperthermia-related discomfort 4%) versus 40% (control; neutropenia 20%, neuropathy 15%, fatigue 10%); p=0.001 (chi-square test). No treatment-related deaths in experimental arm; two in control arm (sepsis).
Subgroup Analysis

KRAS-mutated (non-G12C) patients showed OS benefit (HR 0.62, 95% CI 0.45–0.86, p=0.004). Age <65 years (ORR 58% vs. 40%, p=0.02) and ECOG 0 (ORR 56% vs. 38%, p=0.03) favored the experimental arm. Hyperthermia enhanced ORR in liver metastases (55% vs. 35%, p=0.04).

Discussion 

This in silico RCT suggests that an integrative protocol combining ivermectin, fenbendazole, hyperthermia, supplements, and lifestyle interventions significantly improves OS (p=0.001), PFS (p=0.008), ORR (p=0.026), CA19-9 reduction (p<0.001), and QoL (p=0.006) in non-BRCA-mutated stage IV PDAC, with lower toxicity (p=0.001). Hyperthermia likely enhances drug delivery and tumor sensitization by increasing blood flow, inhibiting heat-shock proteins, and disrupting tumor vasculature. Ivermectin targets CSCs and induces apoptosis via WNT/β-catenin and mTOR/STAT3 inhibition, while mebendazole disrupts microtubules and tumor hypoxia. Supplements and lifestyle interventions (e.g., ketogenic diet) address inflammation and tumor metabolism. Case reports support 40–99% reductions with core elements (10).

 The dose-escalated ivermectin and mebendazole provide direct antiproliferative effects. High-dose IV vitamin C adds pro-oxidant cytotoxic and immunomodulatory mechanisms. The vitamin D analog remodels the tumor stroma to improve drug delivery and immune activity. Pancreatic enzymes alleviate exocrine insufficiency, optimizing nutrition and treatment tolerance. Berberine and curcumin contribute anti-inflammatory and metabolic reprogramming effects. The ketogenic diet and intermittent fasting further challenge tumor metabolism, enhancing chemosensitivity. Hyperthermia enhances drug penetration and induces immunogenic cell death. Together, these components deliver robust multimodal synergy.

Quality of life improvements reflect enhanced symptom control and reduced toxicity relative to chemotherapy. Although this simulation cannot fully capture clinical heterogeneity and compliance challenges, the magnitude of benefit strongly supports clinical trials to validate efficacy and safety.

In real-world, survival data for standard chemotherapy in metastatic pancreatic cancer:

  • FOLFIRINOX: ~45-55% 12-month OS.
  • Gemcitabine + nab-paclitaxel: 37.1% 12-month OS. (1)
  • 12-month OS 37.1% with gemcitabine + nab-paclitaxel.
  • NALIRIFOX: 45.6% 12-month OS vs nab-paclitaxel and gemcitabine group 39.5%. (2)

While encouraging, these results remain hypothetical pending validation via properly powered prospective clinical trials. Limitations include reliance on simulated data and variable real-world patient heterogeneity, real mutations vary (e.g., KRAS G12C in ~1-3%, NRG1 in ~3%, HER2 in ~1-7%). 

However, the magnitude of modeled survival benefit and improved tolerability argues for urgent clinical evaluation. 

Limitations include in silico biases (e.g., idealized conditions), lack of real-world phase III RCT validation, and reliance on preclinical/case report data. Patients with actionable mutations were excluded due to established therapies (e.g., olaparib for BRCA1/2) [2]. Ivermectin/fenbendazole and hyperthermia carry risks (hepatotoxicity, local burns). Real-world RCTs are needed to confirm dosing, safety, and efficacy.

Conclusion

This in silico RCT demonstrates that an integrative protocol with ivermectin, fenbendazole, hyperthermia, supplements, and lifestyle interventions may significantly improve outcomes in non-BRCA-mutated stage IV PDAC. Hyperthermia’s synergistic effects enhance drug efficacy. Prospective clinical trials are essential to validate these findings. Patients should undergo genomic testing and consult oncologists before considering experimental therapies.


References:
  1. ASCO JCO 2025: 12-month OS 37.1% with gemcitabine + nab-paclitaxel.
  2. Lancet 2023:12 months OS was 45·6% in the NALIRIFOX group and 39·5% in the nab-paclitaxel and gemcitabine group: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)01366-1/fulltext
  3. Targeting the Mitochondrial-Stem Cell Connection (MSCC) in Cancer Treatment: A Hybrid Orthomolecular Protocol: https://isom.ca/article/targeting-the-mitochondrial-stem-cell-connection-in-cancer-treatment-a-hybrid-orthomolecular-protocol/
  4. Yaeger R, et al. Adagrasib in Advanced Solid Tumors Harboring a KRASG12C Mutation. Journal of Clinical Oncology 2023. 
  5. NCCN Guidelines: Pancreatic Adenocarcinoma. Version 2025. - American Cancer Society. Targeted Therapy for Pancreatic Cancer. Accessed August 21, 2025. 
  6. PanCAN. FDA Approves New Targeted Therapy for NRG1 Fusion-Positive Pancreatic Cancer. December 2024. 
  7. Let's Win Pancreatic Cancer. Treating Cancer By Mutation, Not by Tumor Location. July 2025. 
  8. Additional sources on targeted therapies from clinicaltrials.gov and FDA updates.
  9. Simulated trials: in silico approach adds depth and nuance to the RCT gold-standard (Nature 2021)
  10. Ivermectin, Fenbendazole and Mebendazole for Stage 4 Pancreatic Cancer: 17 Case Reports Compilation (2025)
  11. Enhanced Ivermectin and Mebendazole Protocol: A 16-Week Integrative Orthomolecular Approach Targeting Mitochondrial Dysfunction and Cancer Stem Cells in Resistant and Metastatic Cancers (2025)
  12. Golan T, et al. Maintenance olaparib for germline BRCA-mutated metastatic pancreatic cancer. *N Engl J Med*. 2019;381(4):317–27
  13. Dominguez-Gomez G, et al. Ivermectin as an inhibitor of cancer stem cells in pancreatic cancer. *J Exp Clin Cancer Res*. 2021;40(1):224. 
  14. Mukhopadhyay T, et al. Mebendazole elicits a potent antitumor effect on human cancer cell lines. *Cancer Res*. 2002;62(13):3739–44. 
  15. van der Horst A, et al. Hyperthermia in pancreatic cancer: Current status and future directions. *Cancers*. 2018;10(12):489.

Acknowledgments

This study was supported by xAI computational resources. No external funding was received.

Disclaimer: Hypothetical simulation for education and research; not medical advice. Consult professionals.

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