Pancreatic Ductal Adenocarcinoma (PDAC)Phase 1/2NCT07595172
NALIRIFOX+Adebrelimab+PULSAR for Advanced Pancreatic Cancer
A Phase 1/2 study testing NALIRIFOX+Adebrelimab and PULSAR in people with Pancreatic Ductal Adenocarcinoma (PDAC) and Locally Advanced and Metastatic Pancreatic Cancer, run by West China Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma (PDAC), Locally Advanced and Metastatic Pancreatic Cancer
- What is being tested?
- NALIRIFOX+Adebrelimab and PULSAR
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- Apr 2026to Mar 2029
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Kexun Zhou, Dr., +028 85423609, kexunzhou@wchscu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC), Locally Advanced and Metastatic Pancreatic Cancer
- Being tested
- NALIRIFOX+Adebrelimab, PULSAR
- Keywords
- chemotherapy, immunotherapy, radiotherapy, PDAC
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NALIRIFOX+AdebrelimabDrug
Also called chemotherapy and immunotherapy
NALIRIFOX chemotherapy and Adebrelimab Injection
PULSARRadiation
Also called Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy
PULSAR
| Study group | Role | What they receive |
|---|---|---|
| NALIRIFOX+Adebrelimab+PULSAR | Experimental | Not described Receives: Drug: NALIRIFOX+Adebrelimab; Radiation: PULSAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (RECIST v1.1)
Measured: From the first patient enrollment until 6 months after the last patient enrollment
Secondary outcomes (3)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
the incidence of adverse events (AE) or severe adverse events (SAE) assessed by CTCAE v4.0
Measured: From the first patient enrollment until 6 months after the last patient enrollment
Progression free survival
Measured: From the first patient enrollment until 6 months after the last patient enrollment
Overall survival
Measured: From the first patient enrollment until 6 months after the last patient enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study startApr 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Ductal Adenocarcinoma (PDAC)Studies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Wang Xin, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595172
- Sponsor's protocol ID
- PRIM-P1
- Status last verified
- May 2026
- First submitted
- 9 Apr 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
Moore C, Hsu CC, Chen WM, Chen BPC, Han C, Story M, Aguilera T, Pop LM, Hannan R, Fu YX, Saha D, Timmerman R. Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy (PULSAR) in Preclinical Models Enhances Single-Agent Immune Checkpoint Blockade. Int J Radiat Oncol Biol Phys. 2021 Aug 1;110(5):1306-1316. doi: 10.1016/j.ijrobp.2021.03.047. Epub 2021 Mar 29.
PubMed 33794306Peng H, Moore C, Zhang Y, Saha D, Jiang S, Timmerman R. An AI-based approach for modeling the synergy between radiotherapy and immunotherapy. Sci Rep. 2024 Apr 8;14(1):8250. doi: 10.1038/s41598-024-58684-6.
PubMed 38589494Rouf S, Moore C, Saha D, Nguyen D, Bleile M, Timmerman R, Peng H, Jiang S. PULSAR Effect: Revealing potential synergies in combined radiation therapy and immunotherapy via differential equations. J Theor Biol. 2025 Jan 7;596:111974. doi: 10.1016/j.jtbi.2024.111974. Epub 2024 Oct 22.
PubMed 39448025Peng H, Moore C, Saha D, Jiang S, Timmerman R. Understanding the PULSAR effect in combined radiotherapy and immunotherapy using transformer-based attention mechanisms. Front Oncol. 2024 Dec 2;14:1497351. doi: 10.3389/fonc.2024.1497351. eCollection 2024.
PubMed 39687891Wainberg ZA, Melisi D, Macarulla T, Pazo Cid R, Chandana SR, De La Fouchardiere C, Dean A, Kiss I, Lee WJ, Goetze TO, Van Cutsem E, Paulson AS, Bekaii-Saab T, Pant S, Hubner RA, Xiao Z, Chen H, Benzaghou F, O'Reilly EM. NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised, open-label, phase 3 trial. Lancet. 2023 Oct 7;402(10409):1272-1281. doi: 10.1016/S0140-6736(23)01366-1. Epub 2023 Sep 11.
PubMed 37708904Cho YB, Yoon N, Suh JH, Scott JG. Radio-immune response modelling for spatially fractionated radiotherapy. Phys Med Biol. 2023 Aug 7;68(16):165010. doi: 10.1088/1361-6560/ace819.
PubMed 37459862Moon EJ, Petersson K, Olcina MM. The importance of hypoxia in radiotherapy for the immune response, metastatic potential and FLASH-RT. Int J Radiat Biol. 2022;98(3):439-451. doi: 10.1080/09553002.2021.1988178. Epub 2021 Nov 2.
PubMed 34726575Galluzzi L, Aryankalayil MJ, Coleman CN, Formenti SC. Emerging evidence for adapting radiotherapy to immunotherapy. Nat Rev Clin Oncol. 2023 Aug;20(8):543-557. doi: 10.1038/s41571-023-00782-x. Epub 2023 Jun 6.
PubMed 37280366Zhu X, Liu W, Cao Y, Feng Z, Zhao X, Jiang L, Ye Y, Zhang H. Immune profiling of pancreatic cancer for radiotherapy with immunotherapy and targeted therapy: Biomarker analysis of a randomized phase 2 trial. Radiother Oncol. 2024 Jan;190:109941. doi: 10.1016/j.radonc.2023.109941. Epub 2023 Oct 10.
PubMed 37820884Li X, Hou W, Xiao C, Yang H, Zhao C, Cao D. Panoramic tumor microenvironment in pancreatic ductal adenocarcinoma. Cell Oncol (Dordr). 2024 Oct;47(5):1561-1578. doi: 10.1007/s13402-024-00970-6. Epub 2024 Jul 15.
PubMed 39008192Royal RE, Levy C, Turner K, Mathur A, Hughes M, Kammula US, Sherry RM, Topalian SL, Yang JC, Lowy I, Rosenberg SA. Phase 2 trial of single agent Ipilimumab (anti-CTLA-4) for locally advanced or metastatic pancreatic adenocarcinoma. J Immunother. 2010 Oct;33(8):828-33. doi: 10.1097/CJI.0b013e3181eec14c.
PubMed 20842054Lynch C, Pitroda SP, Weichselbaum RR. Radiotherapy, immunity, and immune checkpoint inhibitors. Lancet Oncol. 2024 Aug;25(8):e352-e362. doi: 10.1016/S1470-2045(24)00075-5.
PubMed 39089313Wandmacher AM, Letsch A, Sebens S. Challenges and Future Perspectives of Immunotherapy in Pancreatic Cancer. Cancers (Basel). 2021 Aug 23;13(16):4235. doi: 10.3390/cancers13164235.
PubMed 34439389Brahmer JR, Tykodi SS, Chow LQ, Hwu WJ, Topalian SL, Hwu P, Drake CG, Camacho LH, Kauh J, Odunsi K, Pitot HC, Hamid O, Bhatia S, Martins R, Eaton K, Chen S, Salay TM, Alaparthy S, Grosso JF, Korman AJ, Parker SM, Agrawal S, Goldberg SM, Pardoll DM, Gupta A, Wigginton JM. Safety and activity of anti-PD-L1 antibody in patients with advanced cancer. N Engl J Med. 2012 Jun 28;366(26):2455-65. doi: 10.1056/NEJMoa1200694. Epub 2012 Jun 2.
PubMed 22658128Brautigam K, Skok K, Szymonski K, Rift CV, Karamitopoulou E. Tumor immune microenvironment in pancreatic ductal adenocarcinoma revisited - Exploring the "Space". Cancer Lett. 2025 Jul 10;622:217699. doi: 10.1016/j.canlet.2025.217699. Epub 2025 Apr 7.
PubMed 40204149