Experimental nanoparticle boosts radiation against esophageal cancer
NCT ID NCT04615013
First seen Jun 24, 2026 · Last updated Jul 24, 2026 · Updated 4 times
Summary
This early-phase trial tests a new drug called NBTXR3, which is injected into the tumor and activated by radiation to destroy cancer cells. It is given alongside standard chemotherapy for people with stage II–III esophageal adenocarcinoma. The main goals are to find the safest dose and see if the combination is tolerable. Only 24 participants will be enrolled.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NBTXR3 (a nanoparticle drug activated by radiation)
- What this could lead to
- If it works, this could point toward a new way to enhance radiation and chemotherapy for esophageal cancer, potentially improving tumor control.
- What could go wrong
- This is a very early Phase 1 trial with only 24 participants, focused on safety and dosing. It may not lead to a proven treatment, and side effects from the combination therapy are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2020
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Biopsy proven adenocarcinoma of the cervical or thoracic esophagus or gastroesophageal junction * Adenocarcinoma of the esophagus stages II-III allowed * Medically able to receive chemoradiation. Following chemotherapy regimens are allowed: * Oxaliplatin and fluorouracil (5-FU) or capecitabine * Docetaxel and/or 5-FU or paclitaxel * Carboplatin and paclitaxel * Amenable to undergo the endoscopic ultrasound (EUS) guided injection of NBTXR3 as determined by the investigator or treating physician * Patients with lesions for which the EUS scope is not able to traverse the tumor are allowed on this trial as long as an injection can be performed as per treating physician's discretion * Has at least 1 and up to 4 target lesion(s) in the esophagus that are measurable on cross sectional imaging and repeated measurements (via Response Evaluation Criteria in Solid Tumors \[RECIST\] version \[v\] 1.1) at the same anatomical location should be achievable * Local nodal disease around the esophagus allowed * Nodal target lesions must be \>= 15 mm (short axis) based on computed tomography (CT) (slice thickness of 5 mm or less) or magnetic resonance imaging (MRI) * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Hemoglobin \>= 8.0 g/dL * Absolute neutrophil count (ANC) \>= 1,500/mm\^3 * Platelet count \>= 100,000/mm\^3 * Creatinine =\< 1.5 x upper limit of normal (ULN) * Calculated (Calc.) creatinine clearance \> 30 mL/min * Glomerular filtration ratio \> 40 mL/min per 1.73 m\^2 * Total bilirubin =\< 2.0 mg/dL * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN) * Negative urine or serum pregnancy test =\< 7 days of NBTXR3 injection in all female participants of child-bearing potential * Signed informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study Exclusion Criteria: * Prior radiation or any therapy for the treatment of esophageal cancer * Prior surgical resection of esophageal tumor * Esophageal cancer with radiographic evidence of metastases at screening * At screening, past medical history of: * Esophageal fistula * Tracheoesophageal fistula * Siewert type III tumors * Evidence of bulky disease and/or abutment of tumor above the carina that may result in tracheoesophageal fistulas as determined by the investigator or treating physician * Tumors above the carina without defacement of the fat plane between tumor and the airway are allowed * Known uncontrolled (grade \>= 2) or active esophageal or gastric ulcer disease within 28 days of enrollment * Known contraindication to iodine-based or gadolinium-based intravenous (IV) contrast * Active malignancy, in addition to esophageal cancer except for basal cell carcinoma of the skin or non-metastatic low risk prostate cancer definitively treated and relapse free within at least 3 months from time of screening * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, renal failure, cardiac arrhythmia, or psychiatric illness that would limit compliance with treatment * Known active, uncontrolled (high viral load) human immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection * Female patients who are pregnant or breastfeeding * Women of child-bearing potential and their male partners who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period. Acceptable methods of contraception are those that, alone or in combination, result in a failure rate of \< 1% per year when used consistently and correctly * Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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M D Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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