pd-l1 pet imaging during neoadjuvant (chemo)radiotherapy in esophageal and rectal cancer

Conditions: Rectal Cancer Stage; Oesophageal Cancer

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

Keywords: rectal cancer oesophageal cancer chemoradiotherapy short-course preoperative radiotherapy pd-l1 pet 89zr-atezolizumab