Pancreatic Cancer Clinical Trial
Official title:
A Phase 2 Study of Amplitude-Modulated Radiofrequency Electromagnetic Fields in Metastatic Pancreatic Cancer
The objective of this research is to find out what effects (good and bad), the combination of gemcitabine and nab-paclitaxel therapy (GEM-ABR for the rest of the document), standard chemotherapy for pancreatic cancer, and the TheraBionic device has on participants' condition.
Primary Objective(s): The primary objective of this study is to evaluate the efficacy of the combination of nab-paclitaxel, gemcitabine, and amplitude-modulated radiofrequency electromagnetic fields in improving 6-month overall survival (OS) rates in patients with metastatic adenocarcinoma of the pancreas. Secondary Objective(s): - Evaluate the safety and tolerability of the combination of nab-paclitaxel, gemcitabine, and amplitude-modulated radiofrequency electromagnetic fields in patients with metastatic adenocarcinoma of the pancreas. - Evaluate progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) guidelines in patients with metastatic adenocarcinoma of the pancreas treated with the combination of nab-paclitaxel, gemcitabine, and amplitude-modulated radiofrequency electromagnetic fields. - Evaluate the objective response rate (ORR) in patients with metastatic adenocarcinoma of the pancreas treated with the combination of nab-paclitaxel, gemcitabine, and amplitude-modulated radiofrequency electromagnetic fields. - Evaluate the disease control rate (DCR) in patients with metastatic adenocarcinoma of the pancreas treated with the combination of nab-paclitaxel, gemcitabine, and amplitude-modulated radiofrequency electromagnetic fields. ;
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