Stage III Pancreatic Cancer AJCC v8 Clinical Trial
Official title:
Phase I Study of NBTXR3 Activated by Radiotherapy for Locally Advanced or Borderline Resectable Pancreatic Ductal Adenocarcinoma
To find the recommended dose of NBTXR3 that can be given in combination with radiation therapy to patients with pancreatic cancer. To learn if the dose NBTXR3 found in Part 1 can help to control the disease.
PRIMARY OBJECTIVE: • To determine the recommended phase II dose (RP2D) of NBTXR3 activated by radiotherapy in subjects with locally advanced or borderline-resectable pancreatic ductal adenocarcinoma. SECONDARY OBJECTIVES: - To evaluate the safety and feasibility of NBTXR3 intratumoral injection activated by radiotherapy in locally advanced or borderline-resectable pancreatic ductal adenocarcinoma - To evaluate the anti-tumor response of NBTXR3 intratumoral injection activated by radiotherapy in subjects with locally advanced or borderline-resectable pancreatic ductal adenocarcinoma - To evaluate time-to-event outcomes in subjects with locally advanced or borderline-resectable pancreatic ductal adenocarcinoma EXPLORATORY OBJECTIVES: - To evaluate the body kinetic profile of intratumorally injected NBTXR3. - To evaluate time to event outcomes for subjects with clinical staging of locally advanced, unresectable disease. - To evaluate resectability conversion rates. - To evaluate surgical outcomes in subjects who undergo surgery after radiation therapy. - To associate radiomic measurements with outcomes. - To evaluate biomarkers of response in subjects treated with NBTXR3/RT. OUTLINE: This is a dose-escalation study of NBTXR3. Patients receive NBTXR3 intratumorally (IT) on day 1. Patients then undergo 15 fractions of intensity modulated radiation therapy (IMRT) between days 15-43 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 1 month and then every 3 months for up to 1 year. ;
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