Study of Low-Dose Radiation Therapy Combined With Pucotenlimab and Standard Chemotherapy for Patients With Advanced Pancreatic Cancer

What this Trial Is About

Researchers are studying advanced pancreatic cancer, a highly aggressive digestive tract tumor with limited treatment options and a poor prognosis. This trial evaluates whether combining low-dose radiotherapy with the immunotherapy drug Pucotenlimab and standard chemotherapy can improve outcomes by activating the tumors immune environment. The study also aims to develop a model to predict which patients may benefit from this combination, supporting personalized treatment approaches. Participants receive a low dose of radiotherapy 2 Gy to the tumor on the first day of each treatment cycle. On the second day, they are given Pucotenlimab intravenously along with standard chemotherapy, either the AG regimen Gemcitabine and Nab-paclitaxel or the FOLFIRINOX regimen, repeated approximately every three weeks. Treatment continues until the cancer progresses, side effects become unacceptable, or for up to two years. During the study, participants undergo regular assessments to monitor tumor response, including measuring the overall response rate at 6 weeks and disease control and progression-free survival over two years. Safety and feasibility are also evaluated. The trial is open-label and single-arm, conducted at a single center, with ongoing monitoring of treatment effects and patient health throughout participation, which may last up to two years.

LDRT Combined With Pucotenlimab and Standard Therapy for Advanced Pancreatic Cancer: A Single-Arm Study