Slide A new clinical trial studying the treatment of
locally-advanced
pancreatic ductal adenocarcinoma (LA-PDAC)
Despite the advances in immunotherapy, certain cancers such as
locally-advanced pancreatic ductal adenocarcinoma (LA-PDAC) still present significant treatment challenges.

If you, or someone you know has LA-PDAC and is 18 years of age or older, you may want to learn more about the PERIO-03 clinical trial. Talk to your doctor about participating.

The Pressure-Enabled Regional Immuno-Oncology (PERIO-03) clinical trial will study a new investigational drug, SD-101, delivered intravascularly using the TriSalus Infusion System for the Pancreatic Retrograde Venous Infusion (PRVI) of therapeutics. The FDA-cleared TriSalus Infusion System enables use of the Pressure-Enabled Drug Delivery™ (PEDD™) method of administration. The study will evaluate whether this platform approach can improve the performance of systemic checkpoint inhibitors in treating patients with LA-PDAC.
The PERIO-03 clinical trial is studying the ability of SD-101 using the PEDD method of administration to overcome two major challenges of treatment:
  • immunosuppression
  • high intratumoral pressure (ITP)

Studying a Platform Designed

to Address both Treatment Challenges

CHALLENGE 1: Immunosuppression

What happens when there’s a tumor in the pancreas?
What is the significance of MDSCs in the pancreas?
How does investigational SD-101 address the immunosuppressive barrier?
Why is this approach being combined with a checkpoint inhibitor?

CHALLENGE 2: High Intratumoral Pressure (ITP)

How does tumor growth impact treatment?
What is PEDD™?

Am I eligible to participate

in this clinical trial?

You may qualify to participate in the study if you:

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    Are ≥18 years of age with histologically or cytologically confirmed evaluable or measurable locally advanced unresectable PDAC according to RECIST v1.1 criteria.

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    Have suitable venous anatomy on a standard portal venous phase imaging as defined by absence of portal, splenic, or superior mesenteric vein complete occlusion.

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    Have received standard of care chemoradiation therapy or a systemic chemotherapy regimen without a complete radiographic response. Standard of care chemotherapy includes gemcitabine + nab-paclitaxel, or FOLFIRINOX; for others discuss with medical monitor. Radiation with or without concurrent chemotherapy is also acceptable as a standard of care regimen.

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    Have resolved all associated clinically significant (in the judgment of the Investigator) drug-related toxicity from previous cancer therapy (to Grade ≤1 or the patient’s pretreatment level) prior to study treatment administration (Grade 2 alopecia, grade 2 peripheral neuropathy from prior chemotherapy, and endocrinopathies controlled on replacement therapy are allowed).

Get the PERIO-03 clinical trial brochure:

Find a physician affiliated with the
PERIO-03 Clinical Trial

Enrolling Now

The University of Texas MD Anderson
Cancer Center

1515 Holcombe Blvd
Houston, TX 77030
GIClinicalTrials@mdanderson.org

Why should I participate

in a clinical trial?

Virtually every therapy and many medical advancements have been made possible by individuals who take part in clinical trials. Clinical trials are needed for the development of new treatment options for people living with LA-PDAC and other diseases.

REFERENCES

1. Kemp SB, Pasca di Magliano M, Crawford HC. Myeloid Cell Mediated Immune Suppression in Pancreatic Cancer. Cell Mol Gastroenterol Hepatol. 2021;12(5):1531-1542. 2. Medina-Echeverz, J., Eggert, T., Han, M. & Greten, T. F. Hepatic myeloid-derived suppressor cells in cancer. Cancer Immunol. Immunother. 2015;(64)931-940.3. Thyagarajan A, Alshehri MSA, Miller KLR, Sherwin CM, Travers JB, Sahu RP. Myeloid-Derived Suppressor Cells and Pancreatic Cancer: Implications in Novel Therapeutic Approaches. Cancers (Basel). 2019;11(11):1627. doi:10.3390/cancers11111627 4. Thorn M, Guha P, Cunetta M, et al. Tumor-associated GM-CSF overexpression induces immunoinhibitory molecules via STAT3 in myeloid-suppressor cells infiltrating liver metastases. Cancer Gene Ther. 2016;(6):188-198. 5. Wang PF, Song SY, Wang TJ, et al. Prognostic role of pretreatment circulating MDSCs in patients with solid malignancies: A meta-analysis of 40 studies. Oncoimmunology 2018 Jul 30;7(10):e1494113. doi: 10.1080/2162402X.2018.1494113. 6. Yamamoto S., Kuramoto E, Shimada S, and Tokunaga T. “In vitro augmentation of natural killer cell activity and production of interferonalpha/beta and -gamma with deoxyribonucleic acid fraction from Mycobacterium bovis BCG.” Jpn J Cancer Res. 1988;79(7): 866-873. 7. Shirota, H. & Klinman, D. M. Effect of CpG ODN on monocytic myeloid derived suppressor cells. Oncoimmunology 2012;(1):780-782. 8. Ghosh C.C., et al. Regional administration of Class C CpG Oligodeoxynucleotides results in superior intrahepatic TLR9 activation and immunomodulation compared to systemic infusion. Poster presented at AACR. 2021. 9. Stylianopoulos, Triantafyllos, John D. Martin, Matija Snuderl, Fotios Mpekris, Saloni R. Jain, and Rakesh K. Jain. “Coevolution of Solid Stress and Interstitial Fluid Pressure in Tumors During Progression: Implications for Vascular Collapse.” Cancer Research. 2013;(13)73: 3833–41. https://doi.org/10.1158/0008-5472.CAN-12-4521. 10. Jain, Rakesh K. “Barriers to Drug Delivery in Solid Tumors.” Scientific American, 2013;8. 11. Wilhelm S, Tavares A, Dai Q, et al. Analysis of nanoparticle delivery to tumours. Nat Rev Mater. 2016:1. 12. Sheth, Rahul A., Robin Hesketh, David S. Kong, Stephan Wicky, and Rahmi Oklu. 2013. “Barriers to Drug Delivery in Interventional Oncology.” J Vascular and Interventional Radiology. 2013; 24 (8): 1201–1207. https://doi.org/10.1016/j.jvir.2013.03.034. 13. Titano JJ, et al. Cardiovasc Intervent Radiol. 2019;42:560-568. 14. Pasciak AS, et al. J Vasc Interv Radiol. 2015;26:660-669.