To investigate the activating effect of local lesion low-dose radiotherapy (2Gy) on the tumor immune microenvironment, and the efficacy, safety, and feasibility of its combination with pembrolizumab and standard therapy in patients with advanced pancreatic cancer. Concurrently, to preliminarily establish an efficacy prediction model for the early identification of patient populations who would benefit from the treatment, thereby providing a theoretical foundation for the implementation of precision medicine.
Age ≥ 18 years, regardless of gender;
ECOG score of 0 to 1;
Patients with histologically or cytologically confirmed pancreatic malignancy;
No prior treatment with PD-1 or PD-L1 inhibitors;
Previous history of radiotherapy;
Uncontrolled chronic infectious or non-infectious diseases, including but not limited to: medication-refractory heart failure, poorly controlled hypertension, etc.;
Active or clinically uncontrolled severe infections;
History of psychoactive drug abuse that cannot be abstained from, or patients with psychiatric disorders;
Single group
Low-dose Radiotherapy
RadiationAdministered on Day 1 of each cycle. A single fraction of 2 Gy (2Gy/1fx) is delivered to the measurable tumor lesion using 3D-CRT or IMRT techniques.
Pucotenlimab
Biological/VaccineAdministered intravenously (200 mg) on Day 2 of each cycle, every 3 weeks (q3w).
AG regimen
DrugGemcitabine (1000 mg/m\^2) and Nab-paclitaxel (125 mg/m\^2) administered intravenously on Day 1 and Day 8 of each 3-week cycle.
FOLFIRINOX regimen
DrugOxaliplatin (65 mg/m\^2), Irinotecan (140 mg/m\^2), Leucovorin (400 mg/m\^2) on Day 1, followed by 5-FU (2400 mg/m\^2) continuous infusion over 46 hours, every 3 weeks.
ORR
Overall objective tumor response rate
DCR
Disease control rate
PFS
Progression free Survial
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