NALIRIFOX+Adebrelimab+PULSAR for Advanced Pancreatic Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWest China Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
NALIRIFOX+Adebrelimab
DrugNALIRIFOX chemotherapy and Adebrelimab Injection
PULSAR
RadiationPULSAR
Treatment groups
55 Participants
are divided into 1 treatment groupGroup A: NALIRIFOX+Adebrelimab+PULSARExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Objective response rate (RECIST v1.1)
Time frame
From the first patient enrollment until 6 months after the last patient enrollmentSecondary outcomes
1
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
Time frame
From the first patient enrollment until 6 months after the last patient enrollment2
Progression free survival
Time frame
From the first patient enrollment until 6 months after the last patient enrollment3
Overall survival
Time frame
From the first patient enrollment until 6 months after the last patient enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
West China Hospital
Lead sponsor
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov