Actively Recruiting
NBTXR3, Chemotherapy, and Radiation Therapy for the Treatment of Esophageal Cancer
Led by M.D. Anderson Cancer Center · Updated on 2026-04-16
24
Participants Needed
1
Research Sites
361 weeks
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
The purpose of this Phase I study is to determine the recommended phase 2 dose (RP2D) and safety profile of NBTXR3 activated by radiation therapy with concurrent chemotherapy for the treatment of patients with esophageal adenocarcinoma. NBTXR3 is a drug that when activated by radiation therapy, may cause targeted destruction of cancer cells. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as oxaliplatin, fluorouracil, capecitabine, docetaxel, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving NBTXR3 activated by radiation therapy with concurrent chemotherapy may help control the disease.
CONDITIONS
Official 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 stages II-III of the esophagus
- 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 endoscopic ultrasound guided injection of NBTXR3 as determined by the investigator or treating physician
- At least 1 and up to 4 measurable target lesions in the esophagus on imaging, with nodal lesions at least 15 mm in short axis
- ECOG performance status of 0 to 2
- Hemoglobin level of 8.0 g/dL or higher
- Absolute neutrophil count of 1,500/mm3 or higher
- Platelet count of 100,000/mm3 or higher
- Creatinine level less than or equal to 1.5 times the 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 and ALT levels less than or equal to 2.5 times the upper limit of normal
- Negative urine or serum pregnancy test within 7 days before NBTXR3 injection for women of child-bearing potential
- Signed informed consent form indicating understanding and willingness to participate
You will not qualify if you...
- Prior radiation therapy or any treatment for esophageal cancer
- Prior surgical removal of esophageal tumor
- Esophageal cancer with evidence of metastases at screening
- History of esophageal or tracheoesophageal fistula
- Siewert type III tumors
- Bulky disease or tumor abutting above the carina that may cause tracheoesophageal fistulas, unless fat plane between tumor and airway is preserved
- Uncontrolled or active esophageal or gastric ulcer disease within 28 days before enrollment
- Known allergy or contraindication to iodine or gadolinium contrast agents
- Active malignancy other than basal cell skin cancer or low-risk prostate cancer treated and relapse free for at least 3 months
- Uncontrolled illness such as active infection, heart failure, unstable angina, renal failure, arrhythmia, or psychiatric illness limiting treatment compliance
- Known active, uncontrolled HIV, hepatitis B, or hepatitis C infection
- Pregnant or breastfeeding women
- Women of child-bearing potential and their male partners unwilling or unable to use effective birth control during the study
- Any condition that investigator believes would harm participant or interfere with study assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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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