Phase II Study of GnP Chemotherapy Combined With Serplulimab and Stereotactic Body Radiation Therapy as First Treatment for Locally Advanced Pancreatic Cancer

What this Trial Is About

Researchers are evaluating a treatment approach for adults aged 18 to 75 years with locally advanced pancreatic ductal adenocarcinoma, a type of pancreatic cancer confirmed through pathology and imaging studies like CT or MRI. This phase II clinical trial focuses on patients with an ECOG performance status of 0 to 2 and aims to assess the response rate to a combined treatment regimen. Participants receive a combination treatment every 21 days including nab-paclitaxel and gemcitabine on days 1 and 8, along with serplulimab every three weeks. Starting with the second treatment cycle, patients also undergo stereotactic body radiation therapy SBRT targeting the main tumor and nearby lymph nodes using specific radiation doses over five sessions. The choice of radiation dose depends on tumor size and nearby organ sensitivity. Patients are regularly evaluated with tumor markers and CT scans every two cycles, and those eligible may have surgery to remove the tumor. Throughout the study, patients undergo comprehensive assessments including imaging and blood tests to monitor treatment effects and eligibility for surgery. The main outcome measured is the investigator-assessed objective response rate over four years. Safety and disease progression are regularly reviewed by a multidisciplinary team. Participation lasts through treatment cycles and possible surgery, with ongoing evaluations to guide care and study outcomes.

A Study of GnP RegimenCombined With Serplulimab and Stereotactic Body Radiation Therapy as First-line Treatment for Locally Advanced Pancreatic Cancer