NALIRIFOX+Adebrelimab+PULSAR for Advanced Pancreatic Cancer

May 16, 2026 updated by: Wang Xin, West China Hospital

A Phase I/II Clinical Trial of NALIRIFOX Combined With Adebrelimab and PULSAR as First-Line Treatment for Locally Advanced Unresectable or Metastatic Pancreatic Ductal Adenocarcinoma

This study aims to evaluate the safety and preliminary efficacy of NALIRIFOX combined with adebrelimab and PULSAR as first-line treatment for locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC). Additionally, it will explore potential predictive and efficacy-related biomarkers.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

After confirmation of eligibility, enrolled patients will undergo radiation CT simulation and planning per standard of care. IV contrast will be administered with CT simulation at the treating physician's discretion though is not required.

Study Type

Interventional

Enrollment (Estimated)

55

Phase

  • 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 Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age: 18-75 years, regardless of gender.
  • Histologically confirmed pancreatic ductal adenocarcinoma (PDAC).
  • Previously untreated, locally advanced unresectable or metastatic PDAC, with at least one measurable lesion (RECIST v1.1) not previously irradiated.
  • ECOG Performance Status (PS): 0-1.
  • Expected survival ≥ 3 months.
  • Willing and able to comply with study procedures, treatment, and follow-up.
  • No contraindications to radiotherapy.
  • Adequate organ function: WBC ≥ 2.5×10⁹/L, ANC ≥ 1.5×10⁹/L; Platelets ≥ 75×10⁹/L; Hemoglobin (HGB) ≥ 90 g/L (no transfusion or EPO dependence within 7 days); Total bilirubin (Tbil) ≤ 1.5×ULN; ALT/AST ≤ 5×ULN;Albumin ≥ 30 g/L; INR ≤ 1.5×ULN; Serum creatinine (Cr) ≤ 1.5×ULN Urine protein ≤ 1+
  • HBsAg-positive patients must have HBV-DNA ≤ 1×10³ IU/mL (copies/mL). If HBV-DNA ≥ 1×10³ IU/mL, patients may still be eligible if chronic HBV is stable and not expected to increase risk, per investigator assessment.
  • Voluntary participation with signed informed consent form.

Exclusion Criteria:

  • History of severe hypersensitivity to chimeric, human(ized) antibodies, or fusion proteins.
  • Pregnant or breastfeeding women, or men/women of childbearing potential unwilling/unable to use effective contraception during the study.
  • Other malignancies within 5 years, except: Malignancies treated with curative intent and no known active disease for ≥5 years with low recurrence risk; Adequately treated non-melanoma skin cancer or lentigo maligna without disease evidence; Adequately treated carcinoma in situ (e.g., cervical, breast) with no current disease.
  • Symptomatic moderate/severe pleural effusion or ascites.
  • Active bleeding or coagulopathy (PT >16s, APTT >43s, INR >1.5×ULN), bleeding tendency, or current use of thrombolytics/anticoagulants/antiplatelets.
  • GI bleeding within 6 months or high bleeding risk (e.g., active ulcer with occult blood++). If occult blood+ persists, endoscopy required.
  • High-risk esophageal/gastric varices needing intervention.
  • History of drug abuse, psychiatric disorder, or inability to abstain.
  • Solid organ/bone marrow transplant, or active autoimmune disease requiring systemic treatment within 2 years.
  • Immunodeficiency or HIV infection.
  • Objective evidence of pulmonary fibrosis, interstitial lung disease, pneumoconiosis, radiation-/drug-induced pneumonitis, or severely impaired pulmonary function.
  • Major surgery within 4 weeks or minor surgery within 1 week (e.g., tooth extraction).
  • Vaccination within 30 days before the first dose.
  • Abdominal fistula, GI perforation, or abscess within 4 weeks.
  • Any clinically significant abnormality affecting safety per investigator, including: Active infection requiring systemic therapy; Uncontrolled diabetes/hypertension (BP >140/90 mmHg despite ≤2 antihypertensives); Myocardial infarction within 6 months; Thyroid dysfunction (>NCI CTCAE v4.0 Grade 1).
  • Other conditions deemed ineligible by the investigator.

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
Intervention / Treatment
Experimental: NALIRIFOX+Adebrelimab+PULSAR
Drug: NALIRIFOX+Adebrelimab
NALIRIFOX chemotherapy and Adebrelimab Injection
Other Names:
  • chemotherapy and immunotherapy
Radiation: PULSAR
PULSAR
Other Names:
  • Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective response rate (RECIST v1.1)
Time Frame: From the first patient enrollment until 6 months after the last patient enrollment
From the first patient enrollment until 6 months after the last patient enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: From the first patient enrollment until 6 months after the last patient enrollment
the incidence of adverse events (AE) or severe adverse events (SAE) assessed by CTCAE v4.0
From the first patient enrollment until 6 months after the last patient enrollment
Progression free survival
Time Frame: From the first patient enrollment until 6 months after the last patient enrollment
From the first patient enrollment until 6 months after the last patient enrollment
Overall survival
Time Frame: From the first patient enrollment until 6 months after the last patient enrollment
From the first patient enrollment until 6 months after the last patient enrollment

Collaborators and Investigators

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

Sponsor

West China Hospital

Collaborators

Jiangsu Hengrui Pharmaceutical Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

April 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

May 16, 2026

First Posted (Actual)

May 19, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 16, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRIM-P1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

IPD will not be shared in order to protect participant confidentiality, in compliance with local data protection regulations and ethical committee requirements. Additionally, IPD sharing is restricted under contractual agreements with study sponsors/partners, who retain data ownership for independent analyses. Given the complexity and size of the dataset (e.g., genomic/imaging data), anonymized IPD sharing is technically unfeasible without risking data integrity. Furthermore, to safeguard intellectual property rights and permit ongoing secondary analyses by the research team, IPD will be retained internally.

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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