1514P - A prospective, single-center, randomized, controlled, evaluator-blinded, feasibility clinical trial for efficacy and safety of a non-tissue destructive compact focused ultrasound system with neoadjuvant FOLFIRINOX in locally advanced or borderline resectable pancreatic cancer

Background

Pancreatic cancer is characterized by a dense fibrous stroma and poor blood supply, which hampers effective drug delivery and treatment outcomes. Hence, there is an immediate necessity of novel therapeutic strategies to improve drug penetration in the tumor microenvironment of pancreas. The ‘IMD10’ System has been developed to optimize focused ultrasound for the purpose of drug delivery in solid tumors. This clinical trial was designed to evaluate the efficacy and safety of concurrent treatment with FOLFIRINOX chemotherapy with the 'IMD10' non-tissue destructive bedside-applicable focused ultrasound device, in patients with locally advanced (LAPC) or borderline resectable pancreatic cancer (BRPC).

Methods

30 patients of LAPC or BRPC participated. The intervention group (N=15) received a total of four combined treatments at two-week intervals for 2 months, followed by standard care. The control group (N=15) received treatment according to the standard FOLFIRINOX regimen. Safety and efficacy were evaluated up to 6 months after the initiation of the first treatment. Primary efficacy assessment variable was the target lesion size change ratio (%), while secondary efficacy evaluations comprised tumor response and objective response rate (ORR). Adverse events were also recorded.

Results

Immediately after completion of the intervention, the target lesion size change ratio was -24.89% in the intervention group and -14.05% in the control group. This trend persisted until 4 months after the intervention. The ORR was 64.3% in the intervention group and 38.5% in the control group, with no significant differences observed in adverse events between the groups.

Conclusions

The target lesion size change ratio was 1.8 times greater in the intervention group, and the ORR was 1.7 times greater compared to the control group. Considering bedside applicable compact size of IMD 10 designed for drug delivery, we believe there are sufficient clinical potentials. However, larger confirmatory clinical trials are needed to further substantiate these findings.

Clinical trial identification

none

Editorial acknowledgement

During the preparation of this work the author(s) used Chat GPT in order to check up grammatical and usage errors. After using this tool/service, the author(s) reviewed and edited the content as needed and take(s) full responsibility for the content of the publication.

Legal entity responsible for the study

J. Y. Lee.

Funding

Korea Medical Device Development Fund grant funded by the Korea Government (the Ministry of Science and ICT, the Ministry of Trade, Industry and Energy, the Ministry of Health & Welfare, the Ministry of Food and Drug Safety) (Project Number: RS-2020-KD000000).

Disclosure

J.Y. Lee: Financial Interests, Personal, Stocks/Shares: IMGT. All other authors have declared no conflicts of interest.