Clinical trial · Interventional
A Study of PEP503(Radio-enhancer) With Radiotherapy and Chemotherapy for Patients With Rectal Cancer
A Phase Ib/II Study of PEP503 (Radioenhancer) With Radiotherapy, in Combination With Concurrent Chemotherapy for Patients With Locally Advanced or Unresectable Rectal Cancer
NCT02465593CI-TRIAL-00055893terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase Ib/II study is a prospective, open-label, single arm, nonrandomized study of PEP503(radio-enhancer). There are 2 portions in this study. * Escalation phase (Part Ib): A 3 + 3 dose escalation study design will be adopted in this phase to identify the recommended injection volume of PEP503 for intratumor injection. * Expansion phase (Part II): Following the confirmation of the recommended volume of intratumor injection, 18 additional patients will be enrolled at the recommended volume level to evaluate for efficacy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil | Drug | Fluorouracil | ALIAS |
| capecitabine | Drug | Capecitabine | ALIAS |
| PEP503 | Drug | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
| surgical resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PEP503+5-FU/capecitabine+Radiotherapy
- description
- Patients will receive PEP503 given as intratumor injection on Day 1, followed by preoperative radiation therapy.
- interventionNames
- Drug: PEP503
- Drug: 5-fluorouracil
- Drug: capecitabine
- Procedure: surgical resection
- Radiation: Radiotherapy
Primary outcomes (3)
- measure
- safety profile /the Dose Limiting Toxicity (DLT)
- timeFrame
- up to 36 months
- description
- Safety as assess the safety profile and determine the Dose Limiting Toxicity (DLT) of PEP503 given as intratumor injection and activated by external beam radiation, with concurrent chemotherapy in patients with unresectable rectal cancer
- measure
- the recommended volume (dose)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria * Histologically proven adenocarcinoma of the rectum which is T3-4, N any, or locally unresectable disease , without evidence of distant metastases (M0) * Distant border of the tumor must be located ≤ 10 cm from the anal verge * Staging with MRI, transrectal ultrasound or CT-scan to confirm stage and resectability * ECOG performance 0 - 1 * Age: 20 - 80 years old * Adequate bone marrow, renal, and hepatic function as: * absolute neutrophil count (ANC) ≥ 1,500/mm3 * platelet count ≥ 100,000/mm3 * total bilirubin ≤ 1.5x the upper limit of normal (ULN) * aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5x ULN * alkaline phosphatase (ALP) ≤ 2.5 x ULN * calculated creatinine clearance ≥ 50 mL/min, or creatinine within normal range * All female patients of childbearing potential must have negative urine pregnancy test within the 7 days prior study treatment with PEP503. Patients must agree to use effective contraception during the study Exclusion Criteria: * Prior history of pelvic radiation therapy * Hypersensitivity to fluoropyrimidine * Uncontrolled serious medical or psychiatric illness * Myocardial infarction or uncontrolled angor pectoris (angina) within the prior 6 months * No more than 4 weeks since prior participation in any investigational drug study * Major surgery within 28 days * Other malignancy within the past 3 years except effectively treated squamous cell or basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum * Cardiovascular disease that would preclude study treatment or follow-up * Informed consent not duly signed and dated to participate in the study
References
Publications (7)
- BACKGROUNDHeald RJ, Ryall RD. Recurrence and survival after total mesorectal excision for rectal cancer. Lancet. 1986 Jun 28;1(8496):1479-82. doi: 10.1016/s0140-6736(86)91510-2. PMID 2425199
- BACKGROUNDColorectal Cancer Collaborative Group. Adjuvant radiotherapy for rectal cancer: a systematic overview of 8,507 patients from 22 randomised trials. Lancet. 2001 Oct 20;358(9290):1291-304. doi: 10.1016/S0140-6736(01)06409-1. PMID 11684209
- BACKGROUNDLubowski DZ. Rectal cancer: the evolving role of adjuvant radiotherapy. ANZ J Surg. 2015 Mar;85(3):99-100. doi: 10.1111/ans.12916. No abstract available. PMID 25732387
- BACKGROUNDTural D, Selcukbiricik F, Yildiz O, Elcin O, Erdamar S, Guney S, Demireli F, Buyukunal E, Serdengecti S. Preoperative versus postoperative chemoradiotherapy in stage T3, N0 rectal cancer. Int J Clin Oncol. 2014 Oct;19(5):889-96. doi: 10.1007/s10147-013-0636-4. Epub 2013 Nov 12. PMID 24218281
- RESULTNel AE, Madler L, Velegol D, Xia T, Hoek EM, Somasundaran P, Klaessig F, Castranova V, Thompson M. Understanding biophysicochemical interactions at the nano-bio interface. Nat Mater. 2009 Jul;8(7):543-57. doi: 10.1038/nmat2442. Epub 2009 Jun 14. PMID 19525947
- DERIVEDHuang CW, Hu HM, Hsu WH, Chen CY, Huang MY, Chen CP, Wei PL, Shen BN, Chang TK, Wang JY. Results of phase Ib/II trial of PEP503 (NBTXR3, radioenhancer) with chemoradiotherapy in patients with rectal cancer. Nanomedicine (Lond). 2025 May;20(9):929-941. doi: 10.1080/17435889.2025.2487411. Epub 2025 Apr 21. PMID 40255171
- DERIVEDHuang CW, Hu HM, Hsu WH, Chen CY, Huang MY, Chen CP, Wei PL, Shen BN, Wang JY. A phase Ib/II trial of PEP503 (NBTXR3, radioenhancer) with radiotherapy and chemotherapy in patients with rectal cancer. Nanomedicine (Lond). 2023 Mar;18(6):511-524. doi: 10.2217/nnm-2022-0186. Epub 2023 May 11.