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

January 22, 2026 updated by: Liu Yang, Zhejiang Provincial People's Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Pancreatic cancer is one of the most malignant digestive tract tumors, with an extremely poor prognosis and a five-year survival rate of less than 10%. Its treatment options are limited. For patients with unresectable, advanced disease, systemic chemotherapy (such as the AG regimen or FOLFIRINOX regimen) is the standard treatment, but the efficacy remains unsatisfactory, with median overall survival struggling to exceed one year.

In recent years, immunotherapy represented by PD-1/PD-L1 inhibitors has achieved revolutionary success in various solid tumors (such as lung cancer, melanoma), bringing hope for long-term survival to patients with advanced cancer. However, in the field of pancreatic cancer, immunotherapy monotherapy has repeatedly faced setbacks. Multiple clinical studies show that immune checkpoint inhibitors have a very low response rate (typically <5%) in unselected patients with advanced pancreatic cancer, with the vast majority failing to benefit. This characteristic of being an immunologically "cold" tumor is largely attributed to the unique tumor microenvironment (TME) of pancreatic cancer: a highly fibrotic stroma, minimal infiltration of cytotoxic T lymphocytes (CTLs), and an abundance of immunosuppressive cells (such as regulatory T cells (Tregs), myeloid-derived suppressor cells (MDSCs)). These factors collectively create a state of immune exclusion and immunosuppression, preventing immune cells from recognizing and attacking tumor cells.

To convert "cold tumors" into "hot tumors," researchers are actively exploring various combination strategies. Among them, the combination of radiotherapy (RT) and immunotherapy shows great potential. Traditionally, radiotherapy was considered merely a local treatment modality. However, recent studies have found that it also has the abscopal effect - where irradiation of one lesion can lead to the shrinkage of non-irradiated, distant lesions. This suggests that radiotherapy can activate a systemic anti-tumor immune response. It is noteworthy that low-dose radiotherapy (e.g., 2Gy) plays a unique role in this process. Unlike high-dose radiotherapy, which primarily causes DNA double-strand breaks in tumor cells, low-dose radiotherapy is more capable of inducing immunogenic cell death (ICD), prompting tumor cells to release antigens and danger signal molecules, thereby enhancing antigen presentation by dendritic cells (DCs) and initiating a T-cell immune response. Multiple preclinical studies have confirmed that 2Gy radiotherapy can effectively promote the cross-presentation of tumor-specific antigens, reduce immunosuppression in the microenvironment, and increase the infiltration of lymphocytes into the tumor site, creating favorable conditions for immunotherapy to take effect.

Based on the above evidence, we propose the following scientific hypothesis: For patients with advanced pancreatic cancer who are insensitive to immunotherapy monotherapy, preemptive intervention using low-dose radiotherapy is expected to remodel the tumor immune microenvironment (TIME), converting it from "cold" to "hot." Subsequently, the follow-up combination of a PD-1 inhibitor (Pucotenlimab) and standard chemotherapy could not only activate the immune system via radiotherapy but also further kill tumor cells and expose more tumor antigens through chemotherapy, potentially suppressing immunosuppressive cells. The synergistic effect of these three modalities is expected to achieve a "1+1+1>3" outcome, potentially breaking through the current therapeutic bottleneck for advanced pancreatic cancer.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Provincial People's Hospital
        • Contact:
        • Principal Investigator:
          • Liu Yang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LDRT + Pucotenlimab + Chemotherapy
Patients will receive low-dose radiotherapy (2Gy/1fx) on Day 1 of each cycle. On Day 2, patients will receive Pucotenlimab (200mg IV) combined with standard chemotherapy (investigator's choice of AG regimen or FOLFIRINOX regimen). Treatment cycles differ slightly based on the chemotherapy regimen chosen but are generally repeated every 3 weeks. Treatment continues until disease progression, unacceptable toxicity, or up to 2 years.
Radiation: 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.
Biological: Pucotenlimab
Administered intravenously (200 mg) on Day 2 of each cycle, every 3 weeks (q3w).
Drug: 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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: 6 weeks
Overall objective tumor response rate
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
DCR
Time Frame: 2 years
Disease control rate
2 years
PFS
Time Frame: 2 years
Progression free Survial
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhejiang Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 31, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pucotenlimab in PDAC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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