Actively Recruiting
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
Led by Zhejiang Provincial People's Hospital ยท Updated on 2026-01-26
10
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
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 tumor's 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.
CONDITIONS
Brief Title
LDRT Combined With Pucotenlimab and Standard Therapy for Advanced Pancreatic Cancer: A Single-Arm Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- ECOG performance status of 0 to 1
- Histologically or cytologically confirmed pancreatic cancer
- No prior treatment with PD-1 or PD-L1 inhibitors
- At least one tumor lesion suitable for radiotherapy (excluding bone metastases)
- Voluntary participation with signed informed consent
You will not qualify if you...
- Previous radiotherapy treatment
- Uncontrolled chronic infectious or non-infectious diseases, including medication-resistant heart failure and poorly controlled hypertension
- Active or uncontrolled severe infections
- History of psychoactive drug abuse or psychiatric disorders
- Pregnant or breastfeeding women, or those unwilling or unable to use effective contraception
- Any other condition that may affect study conduct or result interpretation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years or until disease progression or unacceptable toxicity
Participants receive low-dose radiotherapy to the tumor lesion on Day 1 of each cycle. On Day 2, they receive Pucotenlimab combined with standard chemotherapy (either the AG regimen or FOLFIRINOX regimen). Treatment cycles repeat every 3 weeks until disease progression, unacceptable toxicity, or up to 2 years.
Every 3 weeks treatment visits
Trial Site Locations
Total: 1 location
1
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
L
Liu Yang, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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