Adebrelimab in Combination With NALIRIFOX in Locally Advanced Pancreatic Cancer

Sponsor
Fudan University
Study ID
NCT06475326
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Adebrelimab — DRUG
    Adebrelimab ,20mg/Kg per time, Q4W
  • Oxaliplatin 100 MG — DRUG
    Oxaliplatin: 60mg/m2, Q2W
  • Irinotecan liposome — DRUG
    Irinotecan Liposome: 50mg/m2, Q2W
  • Calcium Folinate — DRUG
    Calcium Folinate: 400mg/m2, Q2W
  • Fluorouracil — DRUG
    Fluorouracil: 2400mg/m2, Q2W

Study Details

In this study, Adebrelimab combined with NALIRIFOX conversion therapy was performed in subjects with locally advanced pancreatic cancer to evaluate the efficacy and safety of conversion therapy with immunotherapy combined with chemotherapy, followed by different treatment methods such as surgery, continued conversion therapy, and advanced systemic therapy according to different transformation outcomes, to improve the survival benefit of subjects with locally advanced pancreatic cancer.

Key Dates

Start date
Jun 5, 2024
Status verified
Aug 2024
Primary completion
Jun 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
87 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Adebrelimab Combined with NALIRIFOX
    Adebrelimab: 20 mg/kg, intravenous infusion, administered on day 1, every four weeks as a cycle (Q4W) Chemotherapy: Oxaliplatin: 60mg/m2, intravenous infusion for 2 hours, administered on day 1 Irinotecan liposome: 50mg/m2, intravenous infusion for more than 90min, administered on the first day LV: 400mg/m2, intravenous infusion for 2 hours, administered on the first day 5-FU: 2400mg/m2, continuous intravenous infusion for 46h, every two weeks as a cycle (Q2W)

Primary Outcome Measure

Surgical Conversion Rate [ Time Frame: 8 weeks ]

Central Contacts

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