Single-arm Clinical Study of Carbon Ion Radiotherapy Combined with Nituzumab and Gemcitabine for Pancreatic Cancer

What this Trial Is About

Researchers are evaluating the combination of carbon ion radiotherapy (CIRT) with nituzumab and gemcitabine in treating locally advanced and metastatic pancreatic cancer. This is a single-center, single-arm, prospective Phase II clinical trial aimed at assessing the safety and effectiveness of this combined treatment approach. The study focuses on patients with inoperable pancreatic ductal adenocarcinoma or those who refuse surgery, aiming to improve tumor control while minimizing damage to normal tissues. Participants will receive CIRT targeting the primary tumor and involved lymph nodes using precise imaging techniques. Treatment includes stratified radiation doses depending on tumor location relative to the gastrointestinal tract, given once daily four or five times a week. Alongside radiation, patients receive intravenous gemcitabine chemotherapy every three weeks and weekly injections of nituzumab for at least four to six cycles. This comprehensive regimen leverages the physical and biological advantages of heavy ion radiation combined with targeted and chemotherapy agents. During the study, participants will be monitored through imaging and clinical assessments to evaluate tumor response and progression-free survival, with follow-up for at least 12 months. Researchers will measure overall survival at one year as the primary outcome, alongside tumor response rates and progression-free survival. Safety and organ function will be closely observed, and participants must consent before starting treatment. The total study duration extends through 2028, providing detailed evaluation of this combined treatment strategy for advanced pancreatic cancer.

Clinical Study of Carbon Ion Radiotherapy for Pancreatic Cancer.