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

Sponsor
University Hospital Hradec Kralove
Study ID
NCT04098432
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Locally Advanced Unresectable Pancreatic Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Dec 3, 2018
Status verified
Sep 2024
Primary completion
Sep 30, 2022
Completion
Sep 30, 2022

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    4-weeks stereotactic radiotherapy followed by nivolumab 3 mg/kg every two weeks

Primary Outcome Measure

Safety - incidence of treatment-related adverse events [ Time Frame: Through study completion, an average of 4 years ]

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