NCT06944106

A Study on Ivonescimab Plus Chemotherapy as Neoadjuvant Therapy for Borderline Resectable Pancreatic Cancer

A Prospective, Single-arm, Phase II Clinical Study on the Efficacy and Safety of Ivonescimab Combined With Gemcitabine and Nab-paclitaxel (AG) Regimen as Neoadjuvant Treatment for Borderline Resectable Pancreatic Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial is a prospective, single-arm, single-center Phase II clinical study aimed at evaluating the efficacy and safety of Ivonescimab combined with the gemcitabine and nab-paclitaxel (AG) regimen as neoadjuvant therapy for borderline resectable pancreatic cancer.

Detailed description

This trial is a prospective, single-arm, single-center Phase II clinical study aimed at evaluating the efficacy and safety of Ivonescimab combined with the gemcitabine and nab-paclitaxel (AG) regimen as neoadjuvant therapy for borderline resectable pancreatic cancer. After signing the informed consent, eligible participants will receive three cycles of Ivonescimab in combination with AG before surgery. Radical surgery will be performed within 4 to 8 weeks after the last treatment. For participants who do not meet the surgical criteria, they may continue to receive three more cycles of the same treatment. If, after six cycles, participants still do not meet the surgical criteria but have stable disease based on imaging, they may continue to receive maintenance therapy with Ivonescimab and gemcitabine/nab-paclitaxel until disease progression, death, or intolerable toxicity. After surgery, the necessity and plan for adjuvant therapy will be determined by the investigator based on the patient's condition. Imaging assessments will be conducted every three months postoperatively until disease recurrence. After recurrence, survival follow-up will be performed every three months.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	AK112	All enrolled subjects will receive Ivonescimab（AK112，a PD-1/VEGF bispecific antibody，20mg/kg Q3W) in combination with gemcitabine and nab-paclitaxel

Timeline

• Start date: 2025-03-28
• Primary completion: 2026-04-28
• Completion: 2027-03-28
• First posted: 2025-04-25
• Last updated: 2025-05-31

Locations

1 site across 1 country: China