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NBTXR3, Chemotherapy, and Radiation Therapy for Esophageal Cancer

This study is testing a new approach for treating esophageal cancer (adenocarcinoma of the esophagus or gastroesophageal junction, stages II-III). It combines standard chemotherapy and radiation therapy with a new treatment called NBTXR3. NBTXR3 is a type of nanoparticle that, when activated by radiation, may help destroy cancer cells more effectively. Researchers want to find the safest and most effective dose of NBTXR3 to use with chemotherapy and radiation. The study will also look at how safe this combination treatment is and how well it shrinks tumors. This study is currently recruiting 24 participants.

Study design
This is a dose-escalation study, meaning participants will receive increasing doses of NBTXR3 to find the best amount. It plans to enroll 24 participants.
What's involved
Participants will receive NBTXR3 injected into their tumor or lymph nodes on day 1, along with standard chemotherapy and radiation. The study will monitor for side effects up to the end of treatment visit (day 85).
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints for safety and dose determination are measured up to the end of treatment visit (day 85).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04615013

NBTXR3, Chemotherapy, and Radiation Therapy for the Treatment of Esophageal Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~24 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:CapecitabineCarboplatinDocetaxelFluorouracilHafnium Oxide-containing Nanoparticles NBTXR3Intensity-Modulated Radiation Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of dose limiting toxicities (DLTs)
Measured over Up to end of treatment visit (day 85)
+1 more outcome measured

Conditions

Cervical Esophagus Adenocarcinoma
Clinical Stage II Esophageal Adenocarcinoma AJCC v8
Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8
Clinical Stage IIB Esophageal Adenocarcinoma AJCC v8
Clinical Stage III Esophageal Adenocarcinoma AJCC v8
Gastroesophageal Junction Adenocarcinoma
Pathologic Stage II Esophageal Adenocarcinoma AJCC v8
Pathologic Stage IIA Esophageal Adenocarcinoma AJCC v8
Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8
Pathologic Stage III Esophageal Adenocarcinoma AJCC v8
Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8
Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8
Thoracic Esophagus Adenocarcinoma

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Esophageal Adenocarcinoma

NCT04615013

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • M D Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Steven H Lin · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Steven H. Lin
[email protected]
713-606-3836
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Incidence of dose limiting toxicities (DLTs)Up to end of treatment visit (day 85)

    Will be coded and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5 criteria. Descriptive summary tables will be produced, providing the DLTs by initial planned dose level of NBTXR3, initial planned volume of NBTXR3 to be injected, the injected volume, the radiation therapy dose given and the details of the concurrent chemotherapy given.

  • Maximum tolerated dose and recommended phase 2 dose (RP2D)Up to end of treatment visit (day 85)

    The Bayesian Optimal Interval design, with accelerated titration, will be used to identify RP2D.