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

Research output: Contribution to journalReview articlepeer-review

1 Citation (Scopus)

Abstract

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).

Original languageEnglish
Pages (from-to)511-524
Number of pages14
JournalNanomedicine
Volume18
Issue number6
DOIs
Publication statusPublished - Mar 2023

Keywords

  • Humans
  • Antineoplastic Agents/therapeutic use
  • Antineoplastic Combined Chemotherapy Protocols
  • Capecitabine/therapeutic use
  • Clinical Trials, Phase I as Topic
  • Clinical Trials, Phase II as Topic
  • Fluorouracil/therapeutic use
  • Prospective Studies
  • Rectal Neoplasms/drug therapy

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