Low-dose local radiotherapy plus pucotenlimab with standard chemotherapy for advanced pancreatic cancer

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

This trial tests whether adding low-dose local radiation and the PD-1 blocker pucotenlimab to standard chemotherapy can help people with advanced, unresectable pancreatic cancer.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Zhejiang Provincial People's Hospital (Academic / other)
• Drugs / interventions: pembrolizumab, Pucotenlimab, chemotherapy, immunotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07312422 on ClinicalTrials.gov

What this trial studies

This single-arm Phase 1/2 study gives patients with advanced pancreatic cancer a short course of low-dose (2 Gy) local radiotherapy to a target lesion combined with the PD-1 inhibitor pucotenlimab and standard systemic chemotherapy (AG or FOLFIRINOX). The trial will monitor safety, feasibility, and anti-tumor activity while collecting tissue and immune markers to see how the radiation changes the tumor immune microenvironment. Investigators will also build a preliminary prediction model to try to identify which patients are most likely to benefit. Primary goals are to define tolerability and early signals of efficacy to guide larger trials.

Who should consider this trial

Good fit: Adults (≥18) with histologically or cytologically confirmed advanced or unresectable pancreatic cancer, ECOG 0–1, a radiotherapy‑eligible target lesion, no prior PD‑1/PD‑L1 therapy, and who can give informed consent are ideal candidates.

Not a fit: Patients with prior radiotherapy, poor performance status, uncontrolled infections or comorbidities, pregnancy, or lesions not suitable for local irradiation are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could increase response rates and extend survival for some patients by making the tumor microenvironment more responsive to immunotherapy.

How similar studies have performed: PD‑1/PD‑L1 drugs alone have shown very low response rates in pancreatic cancer, while early-phase combinations of radiation and immunotherapy have produced limited promising signals but no definitive success yet.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Hangzhou, Zhejiang

• Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Liu Yang, M.D.

Conditions Pancreatic Cancer; PD-L1; PD-1 Inhibitor; LDRT; Proterizumab; pancreatic cancer; PD-1 inhibitor; immunotherapy