Intraperitoneal LSTA1 in CRS-HIPEC

Status Recruiting

Clinical Trial Summary

This Study is designed to test an investigational product (IP) called LSTA1 (Study drug). LSTA1 is a drug designed to improve the delivery of anti-cancer treatments, such as chemotherapy. Improved delivery of chemotherapy may result in improved anti-cancer effects when given with hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with peritoneal metastases. Participants will be randomized to receive LSTA1 with HIPEC or HIPEC alone (without LSTA1) at the time of surgery.

Clinical Trial Description

Given the high recurrence and disease-related mortality in patients with peritoneal metastases from appendiceal, colorectal, and ovarian cancer after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC), use of an agent to improve operative tumor delivery of co-administered anticancer drugs during HIPEC would potentially have significant impact on oncologic outcomes. Safety of LSTA1 has been demonstrated in the context of metastatic pancreatic cancer when administered intravenously with cytotoxic chemotherapy, but the investigators wish to determine its safety and potential efficacy when administered intraperitoneally with HIPEC in patients with peritoneal metastases from appendiceal, colorectal, and ovarian cancer. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06216561
Study type	Interventional
Source	University of California, San Diego
Contact	Joel Baumgartner
Phone	(858) 246-0581
Email	J1baumgartner@health.ucsd.edu
Status	Recruiting
Phase	Phase 1
Start date	November 30, 2023
Completion date	December 2029

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