Stereotactic Radiotherapy + Anti PD-1 Therapy in Patients With Locally Advanced Unresectable Pancreatic Adenocarcinoma
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Nivolumab 3 mg/kg intravenously every two weeks untill disease progression or unacceptable toxicity
The prescribed dose will be 32 Gy in four fractions in four weeks (8 Gy per one fraction).
Klinika Onkologie a radioterapie, Fakultní nemocnice Hradec Králové
Hradec Králové, Czechia
Onkologická klinika, Fakultní nemocnice Olomouc
Olomouc, Czechia
Onkologická klinika, Thomayerova nemocnice
Prague, Czechia
Ústav radiační onkologie, Nemocnice Na Bulovce
Prague, Czechia
Safety - incidence of treatment-related adverse events
Measured by the incidence of adverse events (AEs), serious adverse events (SAEs), deaths
Time frame: Through study completion, an average of 4 years
Safety - incidence of laboratory abnormalities
Biochemistry - Na (mmol/l), K (mmol/l), Cl (mmol/l), Ca (mmol/l), Ca ionized (mmol/l), Mg (mmol/l), P (mmol/l), urea (mmol/l), creatinine (µmol/l), LDH (µkat/l), AST(µkat/l), ALT(µkat/l), ALP(µkat/l), GMT(µkat/l), total bilirubin (µmol/l), conjuged bilirubin (µmol/l), total protein (g/l), albumin (g/l), fasting glucose (mmol/l), amylase (µkat/l), C-reactive protein (mg/l), endocrine panel - TSH (mU/l), Free T3 (pmol/l), Free T4 (pmol/l), hematology - complete blood count (CBC): hemoglobin (g/l), hematocrit (ratio), white blood cells (WBC) (10E9/l), red blood cells (10E12/l), platelets (10E9/l) including differential (all 10E9/l), coagulation - APTT (ratio), PT (ratio)
Time frame: Through study completion, an average of 4 years
Progression free survival
To evaluate progression free survival (median of progression free survival and 1-, 2-year progression free survival)
Time frame: Through study completion, an average of 4 years
Overall survival
To evaluate overall survival (median of overall survival and 1-, 2-year overall survival)
Time frame: Through study completion, an average of 4 years
Relationship of laboratory markers and progression
To evaluate the relationship of laboratory markers (PD-L1 expression, tumor infiltrating lymphocytes presence, neopterin level) to progression status and time related progress of biomarkers (CEA, CA19-9)
Time frame: Through study completion, an average of 4 years
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patient's capacity to fulfill the activities of daily living and quality of life
Assess by questionnaire European Organisation for Research and Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ-C30) questionnaire. The EORTC QLQ-C30 comprises 30 items (i.e. single questions), 24 of which are aggregated into 9 multi-item scales, that is, 5 functioning scales (physical, role, cognitive, emotional and social), 3 symptom scales (fatigue, pain and nausea/vomiting) and one global health status scale. The remaining 6 single-item (dyspnoea, appetite loss, sleep disturbance, constipation, diarrhoea and the financial impact) scales assess symptoms.All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient).
Time frame: Through study completion, an average of 4 years