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

Pancreatic Cancer PD-1 Inhibitor PD-L1 LDRT Proterizumab

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

Inclusion Criteria6

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;
Presence of a radiotherapeutically eligible target lesion (excluding bone metastases);
Subjects voluntarily participate in the study and provide signed informed consent.

Exclusion Criteria6

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;
Pregnant or lactating women, or patients of childbearing potential who are unwilling or unable to adopt effective contraceptive measures;
Other conditions deemed by the investigator as potentially affecting the conduct of the clinical study or the interpretation of study results.

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.