Patients receive NBTXR3 IT on day 1. Patients then undergo 15 fractions of radiation therapy between days 15-43 in the absence of disease progression or unacceptable toxicity.

Borderline Resectable Pancreatic Adenocarcinoma

Locally Advanced Pancreatic Ductal Adenocarcinoma

Resectable Pancreatic Ductal Adenocarcinoma

Stage III Pancreatic Cancer AJCC v8

Hafnium Oxide-containing Nanoparticles NBTXR3

Radiation Therapy

M D Anderson Cancer Center

NBTXR3 Activated by Radiation Therapy for the Treatment of Locally Advanced or Borderline-Resectable Pancreatic Cancer

Phase I Study of NBTXR3 Activated by Radiotherapy for Locally Advanced or Borderline Resectable Pancreatic Ductal Adenocarcinoma

Any grade >= 3 adverse event related to NBTXR3 and/or radiation therapy. Any toxicity (grade >= 3) that is at least possibly related to study drug (NBTXR3) is a DLT. Adverse events will be scored based on National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE v 5.0).

MTD will be determined as the dose for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate 30%.

Feasibility refers to the ability to do intratumoral injection of NBTXR3. The outcome for each patient would be "feasible" or "not feasible."

Will evaluation of the time-course dependent presence of hafnium in blood and urine following NBTXR3 intratumoral injection.

Defined as the proportion of patients without progression 6 months post NBTXR3 injection.

Resection status as assessed macroscopically by surgeon R0- Macroscopically complete tumor removal with negative microscopic surgical margins, R1- Macroscopically complete tumor removal with positive microscopic margins (any or all), and R2- Macroscopically incomplete tumor removal with known or suspected residual gross disease.

hafnium/悪性腫瘍

NBTXR3 Activated by Radiation Therapy for the Treatment of Locally Advanced or Borderline-Resectable Pancreatic Cancer

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