RecruitingPhase 1Phase 2NCT07312422

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

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


Sponsor

Zhejiang Provincial People's Hospital

Enrollment

10 participants

Start Date

Sep 30, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This single-arm study tests a combination of low-dose radiation therapy (LDRT) plus pucotenlimab (an immunotherapy drug) alongside standard chemotherapy in people with advanced pancreatic cancer. Low-dose radiation is used to try to make the immune system more responsive to the immunotherapy. **You may be eligible if...** - You are 18 or older - You have confirmed pancreatic cancer verified by biopsy or cytology - You have not previously received PD-1 or PD-L1 immunotherapy - You have a suitable target site for radiation (excluding bone metastases) - Your overall health is good (ECOG 0–1) **You may NOT be eligible if...** - You have previously received any radiation therapy - You have uncontrolled chronic conditions such as heart failure or uncontrolled infections - You have previously received immunotherapy targeting PD-1 or PD-L1 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONLow-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.

BIOLOGICALPucotenlimab

Administered intravenously (200 mg) on Day 2 of each cycle, every 3 weeks (q3w).

DRUGAG 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.

DRUGFOLFIRINOX 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

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NCT07312422


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