A phase Ib/II trial of PEP503 (NBTXR3, radioenhancer) with radiotherapy and chemotherapy in patients with rectal cancer

Ching-Wen Huang, Huang-Ming Hu, Wen-Hung Hsu, Chiao-Yun Chen, Ming-Yii Huang, Chou-Pin Chen, Po-Li Wei, Bor-Nian Shen, Jaw-Yuan Wang

研究成果: 雜誌貢獻回顧型文獻同行評審

1 引文 斯高帕斯(Scopus)

摘要

Aims: To investigate the safety profile, dose-limiting toxicity and antitumor activity of PEP503 (NBTXR3) nanoparticles with radiotherapy and concurrent chemotherapy in patients with locally advanced or unresectable rectal cancer. Methods: Patients will receive a single intratumoral injection of the nanoparticles, followed by radiotherapy and intravenous infusion of fluorouracil or oral capecitabine concurrently. In phase Ib (escalation phase, 3 + 3 design), volume escalation is based on the tumor volume of 5, 10, 15 and 22% of total baseline tumor volume. In phase II (expansion phase), 18 additional patients will be enrolled. Discussion: This study will be the first prospective, open-label, single-arm, nonrandomized study to investigate the efficacy and safety profile of PEP503 (NBTXR3) nanoparticles with radiotherapy and chemotherapy in these patients. Trial registration number: NCT02465593 (ClinicalTrials.gov).
原文英語
頁(從 - 到)511-524
頁數14
期刊Nanomedicine
18
發行號6
DOIs
出版狀態已發佈 - 3月 2023

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