NCT06429904

Nimotuzumab Plus NALIRIFOX in Locally Advanced Pancreatic Cancer

A Prospective, Single Arm Study of Nimotuzumab Combined With NALIRIFOX in the Treatment of Locally Advanced Pancreatic Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, open-label, single arm clinical study. The main purpose of the study is to evaluate the clinical efficacy and safety of Nimotuzumab combined with NALIRIFOX in the treatment of locally advanced pancreatic cancer (LAPC).

Detailed description

This clinical study is designed as a prospective, open-label, single arm study to evaluate the clinical efficacy and safety of Nimotuzumab combined with NALIRIFOX in the treatment of locally advanced pancreatic cancer (LAPC). Patients will receive Nimotuzumab plus NALIRIFOX as conversion therapy, and imaging assessments (according to RECIST V.1.1 criteria) will be performed every two cycles (every two months) of conversion therapy. The resectability of the primary pancreatic lesion will be judged based on NCCN guidelines and will be determined by a multidisciplinary team of experts. The main endpoint is overall survival (OS). Additional end points included resection rates, progression-free survival (PFS), objective response rate (ORR), safety, etc.

Conditions

• Locally Advanced Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Nimotuzumab+ NALIRIFOX	Drug: Nimotuzumab Patients will receive Nimotuzumab 400 mg weekly or Nimotuzumab 600mg, 600mg, 400mg on Day 1, 8, 15, respectively, 28 days as a cycle, up to 6 cycles. Other Names: h-R3 Drug: NALIRIFOX Patients will receive NALIRIFOX (liposomal irinotecan 50 mg/m2, oxaliplatin 60 mg/m2, leucovorin 400 mg/m2, and fluorouracil 2400 mg/m2, administered sequentially as a continuous intravenous infusion over 46 h) on days 1 and 15 of a 28-day cycle, up to 6 cycles. Other Names: NALIRIFOX

Timeline

• Start date: 2024-05-15
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2024-05-28
• Last updated: 2024-05-28

Locations

1 site across 1 country: China