Phase II Study of Gemcitabine, Cisplatin, and Nab-Paclitaxel Before Surgery for Resectable or Borderline Resectable Pancreatic Cancer

What this Trial Is About

Researchers are evaluating the use of gemcitabine, cisplatin, and nab-paclitaxel as a combined neoadjuvant chemotherapy treatment for patients with resectable or borderline resectable pancreatic ductal adenocarcinoma. This phase II trial aims to determine the major pathological response rate, feasibility, and safety of this treatment before surgery, and also to assess if it enhances immune response in the tumor area. Pancreatic cancer that can be removed by surgery has standard treatment involving surgery and chemotherapy, but this study explores giving chemotherapy first to potentially improve outcomes. Participants receive the study drugs intravenously nab-paclitaxel over 30 minutes, cisplatin over 60 minutes, and gemcitabine over 30 minutes, on days 1 and 15 of each 28-day cycle. Up to four cycles are given if there is no disease progression or unacceptable side effects. After chemotherapy, patients with stable disease or tumor response undergo surgical removal of the tumor. During the study, participants also have biopsies, blood samples, and imaging scans such as CT or MRI before and during treatment. Participants are followed up every 3 to 4 months for up to 24 months after completing treatment to monitor clinical response to chemotherapy and other outcomes. Assessments include pathological response, safety events, radiological response, surgery success, survival, and tumor marker levels. This comprehensive monitoring helps researchers understand how well the treatment works and its effects over time.

Gemcitabine, Cisplatin and Nab-Paclitaxel as Neoadjuvant Treatment for Patients With Resectable or Borderline Resectable Pancreatic Cancer