NH002-mediated Sonoporation With Chemotherapy in Advanced Pancreatic Cancer

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.

Timeline

Start

2026-01-01

Primary completion

2027-12-31

Completion

2027-12-31

Publications

• Background Han F, Wang Y, Dong X, Lin Q, Wang Y, Gao W, Yun M, Li Y, Gao S, Huang H, Li N, Luo T, Luo X, Qiu M, Zhang D, Yan K, Li A, Liu Z. Clinical sonochemotherapy of inoperable pancreatic cancer using diagnostic ultrasound and microbubbles: a multicentre, open-label, randomised, controlled trial. Eur Radiol. 2024 Mar;34(3):1481-1492. doi: 10.1007/s00330-023-10210-4. Epub 2023 Oct 5.
• Background Dimcevski G, Kotopoulis S, Bjanes T, Hoem D, Schjott J, Gjertsen BT, Biermann M, Molven A, Sorbye H, McCormack E, Postema M, Gilja OH. A human clinical trial using ultrasound and microbubbles to enhance gemcitabine treatment of inoperable pancreatic cancer. J Control Release. 2016 Dec 10;243:172-181. doi: 10.1016/j.jconrel.2016.10.007. Epub 2016 Oct 12.
• Background Lin CY, Li JR, Tseng HC, Wu MF, Lin WL. Enhancement of focused ultrasound with microbubbles on the treatments of anticancer nanodrug in mouse tumors. Nanomedicine. 2012 Aug;8(6):900-7. doi: 10.1016/j.nano.2011.10.005. Epub 2011 Oct 25.
• Background Wang-Gillam A, Li CP, Bodoky G, Dean A, Shan YS, Jameson G, Macarulla T, Lee KH, Cunningham D, Blanc JF, Hubner RA, Chiu CF, Schwartsmann G, Siveke JT, Braiteh F, Moyo V, Belanger B, Dhindsa N, Bayever E, Von Hoff DD, Chen LT; NAPOLI-1 Study Group. Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial. Lancet. 2016 Feb 6;387(10018):545-557. doi: 10.1016/S0140-6736(15)00986-1. Epub 2015 Nov 29.

Drugs

Indications