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LDRT Combined With Pucotenlimab and Standard Therapy for Advanced Pancreatic Cancer: A Single-Arm Study
Sponsor: Zhejiang Provincial People's Hospital
Summary
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.
Official title: An Open-label, Single-center, Single-arm Study to Evaluate the Efficacy and Safety of Low-dose Radiation Therapy Combined With Pultelimab and Standard Treatment in Patients With Advanced Pancreatic Cancer
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2025-09-30
Completion Date
2026-10-30
Last Updated
2026-01-26
Healthy Volunteers
No
Interventions
Low-dose Radiotherapy
Administered 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
Administered intravenously (200 mg) on Day 2 of each cycle, every 3 weeks (q3w).
AG regimen
Gemcitabine (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
Oxaliplatin (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.
Locations (1)
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China