CivaSheet Shown to Improve Outcomes for Pancreatic Cancer Patients

CivaTech Oncology Inc. has announced that CivaSheet significantly boosts outcomes for borderline resectable and locally advanced pancreatic cancer patients. CivaSheet, an implantable, targeted, shielded radiation device delivers an aggressive dose immediately to the pancreas region following surgical resection. Studies have been conducted in multi-institutional settings, garnering support from the NIH/NCI and SBIR programs. This is the first analysis of outcomes from one of the participating institutions.

Between 2017-2020, 19 patients received 3-6 months of chemotherapy, radiation (either conventionally fractionated or SBRT) followed by surgery with CivaSheet placement, mostly prospectively on the Phase 1/2 clinical trial (CivaTech Oncology). During the same time period, data were collected for 16 patients matched by demographics, tumor and treatment factors, who did not have CivaSheet placed.

Patients followed in this evaluation were all treated at Virginia Commonwealth University(VCU), Massey Cancer Center, and were followed until date of death or last follow up and assessed for local control, disease-free survival, cause-specific survival and overall survival.

Cox proportional hazards models indicated that treatment with CivaSheet was associated with substantially longer disease-free survival. As shown at the right, approximately 50% of CivaSheet patients survived 2 years without recurrence and at least 30% of patients were alive without recurrence at almost 5 years. In contrast, no non-CivaSheet patients survived two years without recurrence or death from disease.

“These data are strongly compelling and demonstrate significant impact on the increased survival of pancreatic cancer patients,” commented Suzanne Babcock, Chairman of CivaTech Oncology. Patients have no device related toxicity and report a better quality of life without having disease recurrence and subsequent treatment.

VCU radiation oncologist, Emma Fields MD, is excited by these results and noted “many of my patients who had CivaSheet placed are alive and disease free in longterm follow-up. I think this is very exciting and can offer hope to our patients.”

Taylor RJ, Todor D, Kaplan BJ, Stover W, Fields EC. “CivaSheet intraoperative radiation therapy for pancreatic cancer.” Brachytherapy 2022 Mar-Apr;21(2):255-259. Doi:10.1016/j.brachy.2021.10.007