NCT06080854

AG Combined With Immunotherapy and SBRT in Patients With Potentially Resectable Pancreatic Cancer

Efficacy and Safety of AG Combined With Immunotherapy and SBRT in Patients With Potentially Resectable Pancreatic Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy combined with immunotherapy in patients with potentially resectable pancreatic cancer.

Detailed description

Due to the hidden onset and rapid progression of pancreatic cancer, most patients are already locally advanced or have distant metastasis at the time of diagnosis and lose the opportunity for surgery. Even among operable patients, about 50% will have recurrence and metastasis one year after surgery. Therefore, more and more evidence supports neoadjuvant therapy for patients with high risk factors for resectable pancreatic cancer, and conversion therapy followed by surgery for patients with borderline resectable and locally advanced pancreatic cancer. Therefore, the objective of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy combined with immunotherapy in patients with potentially resectable pancreatic cancer.

Conditions

• Pancreatic Carcinoma

Interventions

Type	Name	Description
DRUG	Toripalimab	Toripalimab 240mg administered intravenously on Days 1 of every 3 weeks
DRUG	Gemcitabine	Gemcitabine 1000 mg/m\^2 administered intravenously on Days 1 \& 8 of every 3 weeks
DRUG	Nab paclitaxel	Nab paclitaxel 125 mg/m\^2 administered intravenously on Days 1 \& 8 of every 3 weeks.
OTHER	SBRT	SBRT Radiotherapy plan: Planning gross tumor volume (PGTV) 5Gy\*10 fractions, Planning target volume (PTV) 3Gy\*10 fractions

Timeline

• Start date: 2023-11-10
• Primary completion: 2025-06-06
• Completion: 2026-06-06
• First posted: 2023-10-12
• Last updated: 2023-10-12

Locations

1 site across 1 country: China