NCT05634564

Concurrent Chemoradiotherapy Combined With Immunotherapy in Patients With Potentially Resectable Pancreatic Cancer

Efficacy and Safety of Concurrent Chemoradiotherapy Combined With Immunotherapy in Patients With Potentially Resectable Pancreatic Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (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	Tislelizumab	Tislelizumab 200mg 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	Gemcitabine 125 mg/m\^2 administered intravenously on Days 1 \& 8 of every 3 weeks.
RADIATION	Hypofractionated radiotherapy with simultaneous integrated boost	Radiotherapy plan: Planning gross tumor volume (PGTV) 5Gy\*10 fractions, Planning target volume (PTV) 3Gy\*10 fractions.

Timeline

• Start date: 2020-06-01
• Primary completion: 2023-04-01
• Completion: 2023-12-31
• First posted: 2022-12-02
• Last updated: 2022-12-05

Locations

1 site across 1 country: China