Triple threat: new combo aims to tackle tough pancreatic cancer
NCT ID NCT07595172
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a mix of chemotherapy (NALIRIFOX), an immunotherapy drug (adebrelimab), and a special type of radiation (PULSAR) as a first treatment for people with advanced pancreatic cancer that cannot be removed by surgery. The goal is to see if this combination is safe and helps shrink tumors. About 55 adults aged 18-75 with good overall health and no prior treatment for their advanced cancer can join.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 55 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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West China Hospital, Sichuan University
RECRUITINGChengdu, Sichuan, 610041, China
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