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New treatment option for Pancreatic Ductal Adenocarcinoma (PDAC)
Official title NALIRIFOX+Adebrelimab+PULSAR for Advanced Pancreatic Cancer
ClinicalTrials.gov ID: NCT07595172
What this study is testing
What is NALIRIFOX+Adebrelimab?
NALIRIFOX+Adebrelimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pancreatic ductal adenocarcinoma (pdac).
Also referred to as chemotherapy and immunotherapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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...
- GI bleeding within 6 months or high bleeding risk (e.g., active ulcer with occult blood++). If occult blood+ persists, endoscopy required.
See the full eligibility 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...
- 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.
- 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...
- 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)...
- Other conditions deemed ineligible by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.