Lifespan, Rhode Island’s leading provider of primary care, hospital and specialty care services, and TriSalus Life Sciences, an oncology therapeutics company integrating immunotherapy with disruptive delivery technology to transform the treatment of liver tumors, today announced the activation of a new PERIO-02 clinical trial site on the Lifespan campus, specifically at Rhode Island Hospital located in Providence.

The opening of the Pressure-Enabled Regional Immuno-Oncology (PERIO-02) clinical trial at Rhode Island Hospital represents the next phase in Lifespan’s partnership with TriSalus following the inception of a separate research laboratory in Lifespan’s Coro Building, centered within Providence’s Innovation and Design District. The PERIO-02 trial is studying an investigational drug, SD-101, delivered intravascularly by the TriNav® Infusion System using the Pressure-Enabled Drug Delivery™ (PEDD™) method of administration. The study is evaluating whether this platform approach can improve the performance of systemic checkpoint inhibitors in treating patients with HCC or ICC.

“The activation of this clinical trial site and continued collaboration with TriSalus marks an important milestone in our efforts to offer local access to the latest in cancer research,” said Michael Henderson, JD, MS, LLM, vice president for research and chief research officer, Lifespan. “We look forward to building upon this partnership as a leading cancer research center in Rhode Island.”

While there have been significant advances in immunotherapy, cancers such as HCC and ICC still present unique treatment challenges, such as immune response suppression and high intratumoral pressure, which can prevent optimal delivery and performance of this class of therapy for patients.[1],[2],[3],[4] The PERIO-02 study, which was first initiated at The University of Texas MD Anderson Cancer Center, is using the TriSalus™ Platform to potentially overcome these delivery challenges and enable more patients with liver and pancreatic tumors to benefit from immunotherapy.

Earlier this year, Lifespan and TriSalus announced the opening of a new on-campus laboratory for conducting immunotherapeutic research, leveraging Lifespan’s state-of-the-art vivarium. TriSalus’ pre-clinical team, supported by the company’s Cranston-based clinical team as well as a grant from the Rhode Island Department of Commerce, is leading research to further develop TriSalus’ therapeutic platform and advance medical knowledge of the barriers that can limit the effectiveness of immuno-oncology treatments for patients with liver and pancreatic tumors.

“Expanding the PERIO-02 trial to Lifespan’s campus is an exciting addition for both of our teams and, importantly, for patients across New England,” said Steven C. Katz, MD, FACS, TriSalus Chief Medical Officer. “Broadening our collaboration allows us to go beyond the informative research currently underway to further study our multifaceted approach to potentially improve immune responses for people living with difficult-to-treat cancers.”

Khaldoun Almhanna, MD, MPH, serves as principal investigator for the PERIO-02 trial at Rhode Island Hospital. To learn more about the PERIO-02 trial, visit, or contact the Lifespan Oncology Clinical Research team at (401) 444-5014.

[1] Shirota H, Klinman DM. Effect of CpG ODN on monocytic myeloid derived suppressor cells. Oncoimmunology. 2012;1(5):780-782. doi:10.4161/onci.19731

[2] Hossain DMS, Pal SK, Moreira D, et al. TLR9-Targeted STAT3 Silencing Abrogates Immunosuppressive Activity of Myeloid-Derived Suppressor Cells from Prostate Cancer Patients. Clin Cancer Res. 2015;21(16):3771-3782. doi:10.1158/1078-0432.CCR-14-3145

[3] 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;23(6):188-198. doi:10.1038/cgt.2016.19

[4] Jain RK. Barriers to drug delivery in solid tumors. Sci Am. 1994;271(1):58-65. doi:10.1038/scientificamerican0794-58

Kelly Brennan

Senior Public Relations Officer
Rhode Island Hospital
[email protected]