Liposomal Irinotecan, 5-fluorouracil/Calcium Folinate, Oxaliplatin, and Adebrelimab in Combination With Radiotherapy for Resectable or Borderline Resectable Pancreatic Cancer With Risk Factors：A Prospective Exploratory Study

Sponsor
Ningbo Medical Center Lihuili Hospital
Study ID
NCT07542002
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Irinotecan liposome, 5-fluorouracil/leucovorin, and oxaliplatin, with or without adadelimab. — DRUG
    Neoadjuvant Chemotherapy and Immunotherapy Oxaliplatin for injection: A dose of 85 mg/m² administered via intravenous infusion over 2 hours, or according to the clinical practice of the research center. Irinotecan liposome: A dose of 56.5 mg/m² administered via intravenous infusion over 90 minutes (±30 minutes). Leucovorin calcium: A dose of 200 mg/m² infused intravenously over 30 minutes, or according to the clinical practice of the research center. 5-Fluorouracil: A dose of 2000 mg/m² administered via intravenous infusion over 46-48 hours, or according to the clinical practice of the research center. Adadelimab: 1200 mg administered via intravenous infusion over 30-60 minutes on Day 1, every 4 weeks. Concurrent Short-Course Radiotherapy: Stereotactic body radiation therapy (SBRT) is used to irradiate only the primary tumor and metastatic lymph nodes, without prophylactic irradiation of adjacent regional lymph nodes. The total dose is 25 Gy, delivered in 5 fractions of 5 Gy each.

Study Details

Pancreatic cancer is a highly malignant digestive system tumor with a very poor prognosis. In recent years, both the incidence and mortality rates of pancreatic cancer have shown a marked upward trend worldwide. Global cancer statistics from 2020 indicate that approximately 495,000 new cases of pancreatic cancer are diagnosed annually, with about 466,000 deaths attributed to this disease each year. Based on the anatomical relationship between the tumor and blood vessels, pancreatic cancer is classified into three types: resectable, borderline resectable, and unresectable. The onset of pancreatic cancer is often insidious, with approximately 80% of patients presenting with advanced disease at the time of initial diagnosis, thereby losing the opportunity for radical surgical resection. Only 15-20% of patients are eligible for radical surgery at the time of initial diagnosis. However, even after surgical resection, many patients still experience early recurrence, leading to a very poor prognosis. This highlights the significant limitations of relying solely on surgery for disease control. Currently, there is no standard neoadjuvant treatment protocol for pancreatic cancer. Recent neoadjuvant clinical trials have primarily referenced chemotherapy regimens used for advanced pancreatic cancer, which may include chemotherapy and/or radiotherapy. Recommended chemotherapy regimens include the FOLFIRINOX regimen, gemcitabine plus nab-paclitaxel, gemcitabine plus cisplatin (for BRCA1/2 mutations), and gemcitabine plus S-1. At the 2023 ASCO Annual Meeting, updated data from the NAPOLI-3 study showed that the NALIRIFOX regimen (irinotecan liposome, oxaliplatin, 5-fluorouracil, and leucovorin) achieved overall survival (OS) endpoints in first-line treatment of metastatic pancreatic cancer patients compared to the AG regimen, with clinical significance. Based on this study, the NCCN guidelines have included the NALIRIFOX regimen as a recommended first-line treatment for advanced pancreatic cancer. Given the therapeutic and safety advantages of irinotecan liposome over irinotecan in pancreatic cancer, this study aims to further explore the efficacy and safety of irinotecan liposome, 5-fluorouracil/leucovorin, oxaliplatin, and adabelimab combined with radiotherapy for resectable or borderline resectable pancreatic cancer with high-risk factors. The goal is to identify a more effective treatment option for patients with borderline resectable pancreatic cancer (BRPC) and resectable pancreatic cancer (RPC), thereby improving survival outcomes. This study is a prospective, single-arm, exploratory trial designed to evaluate the efficacy and safety of irinotecan liposome, 5-fluorouracil/leucovorin, oxaliplatin, and adabelimab combined with radiotherapy for resectable or borderline resectable pancreatic cancer with high-risk factors, with a planned enrollment of 37 patients. After screening and meeting the inclusion and exclusion criteria, eligible patients will provide informed consent and undergo neoadjuvant treatment with irinotecan liposome, 5-fluorouracil/leucovorin, oxaliplatin, and adabelimab (with a 2-week cycle) for a total of four cycles of preoperative chemotherapy combined with immunotherapy, along with five sessions of short-course radiotherapy.

Key Dates

Start date
Mar 25, 2025
Status verified
Jul 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
37 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Irinotecan liposome, 5-fluorouracil/leucovorin, and oxaliplatin, with or without adade

Primary Outcome Measure

The R0 resection rate [ Time Frame: Through study completion, an average of 2 year. ]

Central Contacts

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