Clinical trial NCT04564482: PD-L1 PET Imaging During Neoadjuvant (Chemo)Radiotherapy in Esophageal and Rectal Cancer
Official title: Programmed Death-ligand 1 Positron Emission Tomography Imaging During Neoadjuvant (Chemo)radiothErapy in Esophageal and Rectal Cancer (PETNEC): a Prospective Non-randomized Open-label Single-center Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rectal Cancer Stage
Oesophageal Cancer
Keywords: Rectal Cancer
Oesophageal Cancer
Chemoradiotherapy
Short-course preoperative radiotherapy
PD-L1 PET
89Zr-atezolizumab
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The overall aim of this pilot study is to prospectively monitor programmed death-ligand 1 (PD-L1) expression dynamics in vivo, during neoadjuvant chemoradiotherapy (CRT) or short-course preoperative radiotherapy (SCPRT) in rectal and esophageal cancer by a positron emission tomography (PET) imaging approach.


Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* All sexes
* Histologically confirmed carcinoma of the rectum or oesophagus (squamous cell carcinoma and adenocarcinoma, including oesophago-gastric junction cancers)
* Medical need for a neoadjuvant CRT/SCPRT
* Suitable to withstand the course of neoadjuvant CRT/SCPRT
* Written informed consent form (ICF) for participation in the study

Exclusion Criteria:

* Metastatic disease, which is considered incurable by local therapies (expect for oligometastatic disease with a curative intend)
* Previous surgery of the tumor other than biopsy
* Pregnancy, breastfeeding or expectancy to conceive
* Prior therapy with anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2 or any other agent directed against co-inhibitory T cell receptors or has previously participated in clinical studies with immunotherapy
* Disagreement of participants with reproductive potential to use contraception throughout the study period and for up to 180 days after the last dose of study therapy
* Hepatitis B or C
* Human immunodeficiency virus (HIV)
* Immunodeficiency
* Allogeneic tissue or solid organ transplantation
* Autoimmune disease that has required systemic therapy in the past 2 years with modifying agents, steroids or immunosuppressive drugs
* Active non-infectious pneumonitis
* Active infection requiring systemic therapy
* Systemic steroids or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
* Diagnosed and/or treated additional malignancy within 5 years of randomization, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin and/or curatively-resected in situ cervical and/or breast cancers
* Treatment with botanical preparations (i.e. herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks prior to randomization/treatment
* Participants with serious or uncontrolled medical disorders
* Uncontrolled or significant cardiovascular disease (myocardial infarction, uncontrolled angina, any history of clinically significant arrhythmias, QTc prolongation in males \> 450 ms and \> 470 ms in females, participants with history of myocarditis)
* Allergies and adverse drug reaction (history of allergy or hypersensitivity to study drug components, contraindications to any of the study drugs of the chemotherapy regimen)
* Other exclusion criteria: Prisoners or participants who are involuntarily incarcerated, participants who are compulsorily detained for treatment of either a psychiatric or physical (i.e. infectious disease) illness

Primary outcomes:
measure: Intratumoral changes of PD-L1 expression during neoadjuvant CRT/SCPRT
timeFrame: 3 weeks
Secondary outcomes:
measure: Radiographic therapy response
timeFrame: 12 weeks
measure: Pathological therapy response
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Division of Nuclear Medicine, Department of Biomedical Imaging and Image-guided Therapy, Medical University of Vienna
name: Alexander Haug, MD
role: PRINCIPAL_INVESTIGATOR
References: