NCT04098432

STR + Anti PD-1 Therapy in Patients with Locally Advanced Unresectable Pancreatic Adenocarcinoma

Stereotactic Radiotherapy + Anti PD-1 Therapy in Patients with Locally Advanced Unresectable Pancreatic Adenocarcinoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University Hospital Hradec Kralove · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Stereotactic Radiotherapy + Anti PD-1 Therapy in Patients With Locally Advanced Unresectable Pancreatic Adenocarcinoma

Detailed description

Phase I/II, multicentre, open label, with no control arm clinical trial of 4-weeks stereotactic radiotherapy followed by nivolumab 3 mg/kg every two weeks in adults with locally advanced pancreatic cancer who does not progress during 4 cycles of standard chemotherapy FOLFIRINOX

Conditions

• Locally Advanced Unresectable Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab 3 mg/kg intravenously every two weeks untill disease progression or unacceptable toxicity
RADIATION	Stereotactic radiotherapy	The prescribed dose will be 32 Gy in four fractions in four weeks (8 Gy per one fraction).

Timeline

• Start date: 2018-12-03
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2019-09-23
• Last updated: 2024-09-23

Locations

4 sites across 1 country: Czechia