NH002-mediated Sonoporation With Chemotherapy in Advanced Pancreatic Cancer
brief summary
This is a phase I study that will enroll patients with pancreatic cancer and liver metastasis who have failed prior gemcitabine-based chemotherapy. Patients will be treated with nanoliposomal irinotecan plus 5-FU and leucovorin and NH002-based sonoporation to the liver metastasis.
detailed description
With dose escalation under the 3+3 phase I design, NH002-based sonoporation will be performed in 4 cohorts. In cohort 1, NH002 will be given with one short course of sonoporation (on Cycle 1 Day 1). In cohort 2, NH002 will be given with one long course of sonoporation (on Cycle 1 Day 1). In cohort 3, NH002 will be given with two long courses of sonoporation (on Cycle 1 Day 1 and Day 2). In cohort 4, NH002 will be given with three long courses of sonoporation (on Cycle 1 Days 1, 2, and 3). During the NH002-based sonoporation, chemotherapy with standard dose of nanoliposomal irinotecan plus 5-FU and leucovorin will be administered concomitantly. The primary endpoint is safety parameters and to determine the dose-limiting toxicity and maximum tolerated dose.
official title
A Phase I Study of NH002-mediated Sonoporation With Nanoliposomal Irinotecan, Leucovorin, and 5-Fluorouracil in Pancreatic Ductal Adenocarcinoma Patients With Liver Metastasis