Actively Recruiting
A Phase 1 Study of NBTXR3 Activated by Radiotherapy With Concurrent Chemotherapy for Adenocarcinoma of the Esophagus
Led by M.D. Anderson Cancer Center · Updated on 2026-04-16
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the recommended dose and safety of NBTXR3, a drug containing hafnium oxide nanoparticles, when activated by radiation therapy combined with chemotherapy for patients with esophageal adenocarcinoma. This Phase 1 study focuses on patients with treatment-naive adenocarcinoma of the esophagus, aiming to understand how NBTXR3 works with standard chemoradiation to control the disease and assess its anti-tumor effects and time-to-event outcomes. Additional goals include studying the drug's distribution, surgical outcomes, imaging measurements, and immune-related responses. Participants receive NBTXR3 through injection directly into the tumor or nearby lymph nodes on day 1. Starting on day 15, they undergo intensity-modulated radiation therapy (IMRT) five days a week for six weeks, totaling 28 treatment sessions, as long as the disease does not progress and side effects remain acceptable. Concurrently, patients receive one of several chemotherapy regimens selected by their physician, including combinations of fluorouracil, oxaliplatin, capecitabine, docetaxel, paclitaxel, or carboplatin. Throughout the study, patients are closely monitored for dose-limiting toxicities and safety up to day 85. Follow-up visits occur every three months for one year to evaluate late-onset side effects, tumor response, progression-free survival, and overall survival. Researchers also assess the feasibility of NBTXR3 injections, pathological responses, and radiographic disease progression. The total participation duration includes treatment and one year of follow-up to understand the therapy's effects and safety profile.
CONDITIONS
Brief Title
NBTXR3, Chemotherapy, and Radiation Therapy for the Treatment of Esophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 with allowed chemotherapy regimens including oxaliplatin and fluorouracil or capecitabine, docetaxel and/or fluorouracil or paclitaxel, or carboplatin and paclitaxel
- Amenable to undergo endoscopic ultrasound guided injection of NBTXR3 as determined by investigator or physician
- Patients with lesions that EUS scope cannot traverse allowed if injection can be performed
- At least 1 and up to 4 measurable target lesions in the esophagus on imaging with repeat measurement possible
- Local nodal disease around the esophagus allowed
- Nodal target lesions must be at least 15 mm on CT or MRI
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Hemoglobin at least 8.0 g/dL
- Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- Creatinine less than or equal to 1.5 times upper limit of normal
- Calculated creatinine clearance greater than 30 mL/min
- Glomerular filtration rate greater than 40 mL/min per 1.73 m2
- Total bilirubin less than or equal to 2.0 mg/dL
- AST/ALT less than or equal to 2.5 times upper limit of normal
- Negative pregnancy test within 7 days of NBTXR3 injection for females of child-bearing potential
- Signed informed consent form indicating understanding and willingness to participate
You will not qualify if you...
- Prior radiation or any therapy for esophageal cancer
- Prior surgical removal of esophageal tumor
- Esophageal cancer with evidence of metastases at screening
- History of esophageal or tracheoesophageal fistula
- Presence of Siewert type III tumors
- Bulky disease or tumor abutting above the carina that may cause tracheoesophageal fistulas unless fat plane preserved
- Uncontrolled or active esophageal or gastric ulcer disease within 28 days before enrollment
- Contraindication to iodine-based or gadolinium-based IV contrast
- Active malignancy other than treated basal cell skin cancer or low risk prostate cancer relapse free for at least 3 months
- Uncontrolled illnesses such as infection, heart failure, unstable angina, renal failure, arrhythmia, or psychiatric illness limiting treatment compliance
- Active, uncontrolled HIV or hepatitis B or C infection
- Pregnant or breastfeeding females
- Women of child-bearing potential and male partners unwilling or unable to use effective birth control during the study
- Any condition that may compromise participant well-being or protocol assessments as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks (day 1 to day 85)
Participants receive a single injection of NBTXR3 nanoparticles into the tumor or nearby lymph nodes on day 1. Starting on day 15, participants undergo radiation therapy 5 days per week for 6 weeks, concurrently receiving chemotherapy according to their assigned regimen.
Daily visits for radiation therapy 5 days per week for 6 weeks plus chemotherapy visits concurrent with radiation
Duration - 1 year
After completing the treatment, participants are followed up every 3 months for 1 year to monitor safety, tumor response, and survival outcomes.
Visits every 3 months for up to 1 year
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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