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 -
