Trials / Recruiting

RecruitingNCT04615013

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

A Phase 1 Study of NBTXR3 Activated by Radiotherapy With Concurrent Chemotherapy for Adenocarcinoma of the Esophagus

Status: Recruiting
Phase: Phase 1
Study type: Interventional
Enrollment: 24 (estimated)

Sponsor: M.D. Anderson Cancer Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. To determine the recommended phase II dose (RP2D) of hafnium oxide-containing nanoparticles NBTXR3 (NBTXR3) activated by radiotherapy with concurrent chemotherapy, per standard of care, for treatment naive patients with adenocarcinoma of the esophagus. SECONDARY OBJECTIVES: I. To evaluate the safety and feasibility of radiation with NBTXR3 in patients with adenocarcinoma of the esophagus. II. To evaluate the anti-tumor response of chemoradiation with NBTXR3 in patients with adenocarcinoma of the esophagus. III. To evaluate time-to-event outcomes after chemoradiation with NBTXR3 in patients with adenocarcinoma of the esophagus. EXPLORATORY OBJECTIVES: I. To evaluate the body kinetic profile of intratumorally/intranodally injected NBTXR3. II. To evaluate time to event outcomes for patients with clinical staging of locally advanced, unresectable disease. III. To evaluate surgical outcomes in patients who undergo surgery after study treatment. IV. To evaluate radiomic measurements with outcomes. V. To assess immune-related biomarkers of response. OUTLINE: This is a dose-escalation study of NBTXR3. Patients receive NBTXR3 intratumorally (IT) or intranodally (IN) on day 1. Beginning day 15, patients undergo intensity-modulated radiation therapy (IMRT) 5 days per week for 6 weeks for a total of 28 fractions in the absence of disease progression or unacceptable toxicity. Beginning on day 15, concurrent with IMRT, patients receive a chemotherapy regimen consisting of either fluorouracil and oxaliplatin with or without leucovorin, oxaliplatin and capecitabine, docetaxel and fluorouracil with or without leucovorin, docetaxel and paclitaxel, or carboplatin and paclitaxel per physician discretion. After completion of study treatment, patients are followed up every 3 months for 1 year.

Conditions

Interventions

Type	Name	Description
DRUG	Capecitabine	Not applicable to this study
DRUG	Carboplatin	Not applicable to this study
DRUG	Docetaxel	Not applicable to this study
DRUG	Fluorouracil	Not applicable to this study
OTHER	Hafnium Oxide-containing Nanoparticles NBTXR3	Given IT or IN
RADIATION	Intensity-Modulated Radiation Therapy	Undergo IMRT
DRUG	Leucovorin	Not applicable to this study
DRUG	Oxaliplatin	Not applicable to this study
DRUG	Paclitaxel	Not applicable to this study

Timeline

Start date: 2020-11-23
Primary completion: 2027-10-31
Completion: 2027-10-31
First posted: 2020-11-04
Last updated: 2026-04-16

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT04615013. Inclusion in this directory is not an endorsement.