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

doi:10.2217/nnm-2022-0186

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 journal › Review article › peer-review

15 Citations (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 language	English
Pages (from-to)	511-524
Number of pages	14
Journal	Nanomedicine
Volume	18
Issue number	6
DOIs	https://doi.org/10.2217/nnm-2022-0186
Publication status	Published - Mar 2023

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

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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10.2217/nnm-2022-0186

Cite this

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

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).",

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

year = "2023",

month = mar,

doi = "10.2217/nnm-2022-0186",

language = "English",

volume = "18",

pages = "511--524",

journal = "Nanomedicine",

issn = "1743-5889",

publisher = "Taylor and Francis Ltd.",

number = "6",

}

TY - JOUR

T1 - A phase Ib/II trial of PEP503 (NBTXR3, radioenhancer) with radiotherapy and chemotherapy in patients with rectal cancer

AU - Huang, Ching-Wen

AU - Hu, Huang-Ming

AU - Hsu, Wen-Hung

AU - Chen, Chiao-Yun

AU - Huang, Ming-Yii

AU - Chen, Chou-Pin

AU - Wei, Po-Li

AU - Shen, Bor-Nian

AU - Wang, Jaw-Yuan

PY - 2023/3

Y1 - 2023/3

N2 - 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).

AB - 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).

KW - Humans

KW - Antineoplastic Agents/therapeutic use

KW - Antineoplastic Combined Chemotherapy Protocols

KW - Capecitabine/therapeutic use

KW - Clinical Trials, Phase I as Topic

KW - Clinical Trials, Phase II as Topic

KW - Fluorouracil/therapeutic use

KW - Prospective Studies

KW - Rectal Neoplasms/drug therapy

U2 - 10.2217/nnm-2022-0186

DO - 10.2217/nnm-2022-0186

M3 - Review article

C2 - 37166053

SN - 1743-5889

VL - 18

SP - 511

EP - 524

JO - Nanomedicine

JF - Nanomedicine

IS - 6

ER -

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

Abstract

UN SDGs

Keywords

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