NCT06766019

Adebrelimab Combined With Irinotecan Liposomal (II), Oxaliplatin, and 5-FU/LV Conversion Therapy for Locally Advanced Pancreatic Cancer

Adebrelimab Combined With Irinotecan Liposomal (II), Oxaliplatin, and 5-FU/LV Conversion Therapy for Locally Advanced Pancreatic Cancer: a Prospective, Single-arm, Exploratory Clinical Study

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This trial is a prospective, single-arm, single-center, phase II clinical study, mainly targeting subjects with locally advanced pancreatic cancer, to explore the efficacy and safety of adebrelimab combined with irinotecan liposome (II), oxaliplatin, and 5-FU/LV conversion in the treatment of locally advanced pancreatic cancer.

Detailed description

Subjects enter the screening period after being fully informed and signing an informed consent form. The screening period for the study is 28 days. After completing the screening inspection and evaluation, patients will receive adebrelimab once and irinotecan liposomal (II), oxaliplatin, 5-FU/LV twice per cycle (4 weeks), and imaging of tumor lesions will be performed every 2 cycles (8 weeks ± 7 days) to evaluate whether patients can undergo surgery until surgical resection, disease progression, or intolerable toxicity, start of new anticancer drug therapy, withdrawal from the study, death, or loss to follow-up. After 6 cycles of treatment, patients who are assessed to have no progression but are still unable to undergo radical surgical resection will receive maintenance treatment regimen (using capecitabine or teggio plus adebrelimab), and imaging efficacy will be evaluated every 12 weeks (± 7 days) during maintenance treatment. Surgical resectability will still be evaluated during maintenance treatment until disease progression or intolerable toxicity, start of new anticancer drug treatment, withdrawal from the study, death, or loss to follow-up.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Adebrelimab combined with irinotecan liposomal (II), oxaliplatin, and 5-FU/LV	1. adebrelimab 1200mg, i.v. D1, q28d 2. irinotecan liposomal (II) 60mg/m\^2, i.v. D1, Q2W 3. oxaliplatin 85mg/m\^2, i.v. D1, Q2W 4. 5-FU/LV 2400mg/400mg/m\^2, i.v. D1, Q2W 4-week cycles, 6 cycles

Timeline

• Start date: 2024-10-16
• Primary completion: 2027-09-30
• Completion: 2027-09-30
• First posted: 2025-01-09
• Last updated: 2025-01-09

Locations

1 site across 1 country: China