Trial reportNanomedicine (London, England)2025
Results of phase Ib/II trial of PEP503 (NBTXR3, radioenhancer) with chemoradiotherapy in patients with rectal cancer.
Trial report in Nanomedicine (London, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02465593 (A Phase Ib/II Study of PEP503), which is not on this map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase Ib/II Study of PEP503 (Radioenhancer) With Radiotherapy, in Combination With Concurrent Chemotherapy for Patients With Locally Advanced or Unresectable Rectal Cancer
Who cites it
3 citing papers in PubMed.
- Beyond apoptosis: nanomedicine enabled reprogramming of tumor cell death for next-generation radiosensitization.Journal of nanobiotechnology · 2026Review
- Hafnium-Oxide Based Nanoplatform with Tumor Microenvironment Responsive Drug Release for Enhanced Radio-Chemotherapy.International journal of nanomedicine · 2026Article
- The radioenhancer NBTXR3: bridging physics and biology to improve radiotherapy outcomes and prime anti-tumor immunity.Journal of experimental & clinical cancer research : CR · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimTo evaluate the efficacy, recommended phase II dose (RP2D), dose-limiting toxicity (DLT), and safety profiles of PEP503 (NBTXR3) in combination with concurrent chemoradiotherapy (CCRT) in patients with locally advanced or unresectable rectal adenocarcinoma.
methodsA single administration of intratumor injection of PEP503 (NBTXR3) (multiple punctures) was applied, followed by radiotherapy in combination with capecitabine or 5-fluorouacil (5-FU). Surgery was performed 8 to 12 weeks after completion of CCRT.
resultsThirty-two patients were enrolled (one dropped out before CCRT), comprising 20 in phase Ib and 12 in phase II. The disease control rate was 100% (
conclusionIntratumor injection of PEP503 (NBTXR3) in patients with locally advanced or unresectable rectal adenocarcinoma is safe and effective. Addition of PEP503 (NBTXR3) to fluoropyrimidine-based neoadjuvant CCRT does not engender increased toxicity. The strong safety profile and encouraging efficacy of PEP503 (NBTXR3) in combination with neoadjuvant CCRT in locally advanced or unresectable rectal cancer warrant further examination in clinical studies. CLINICAL
trial registrationThis study was registered on ClinicalTrials.gov Identifier: NCT02465593.
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