NALIRIFOX plus adebrelimab and PULSAR as first-line treatment for advanced pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase trial evaluates the safety and preliminary efficacy of combining NALIRIFOX chemotherapy with adebrelimab, an immunotherapy agent, and PULSAR as first-line treatment for patients with locally advanced unresectable or metastatic PDAC. Eligible participants will undergo standard radiation CT simulation and planning, with IV contrast at the clinician’s discretion. The study also explores biomarkers that may predict response and help interpret efficacy signals. Enrollment includes adults 18-75 with good performance status and adequate organ function, and requires measurable disease and no prior radiotherapy to target lesions. Outcomes will focus on safety, tolerability, and initial anti-tumor activity, with biomarker correlations planned.

Why it matters

Who can join: the full rules

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.

Where it's running

• West China Hospital, Sichuan University
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Kexun Zhou, Dr.
• Email: kexunzhou@wchscu.cn
• Phone: +028 85423609

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.