Monitoring PD-L1 expression in esophageal and rectal cancer during treatment
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
This study is testing how levels of a protein called PD-L1 change in patients with esophageal and rectal cancer during their treatment to see if it can help improve future therapies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Vienna) |
| Trial ID | NCT04564482 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to monitor the dynamics of programmed death-ligand 1 (PD-L1) expression in patients with rectal and esophageal cancer during neoadjuvant chemoradiotherapy (CRT) or short-course preoperative radiotherapy (SCPRT). Using positron emission tomography (PET) imaging, the study will assess how PD-L1 levels change in vivo throughout the treatment process. The goal is to better understand the role of PD-L1 in these cancers and potentially improve treatment strategies. Participants will be closely monitored to evaluate the effectiveness of the imaging approach.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed rectal or esophageal carcinoma requiring neoadjuvant CRT or SCPRT.
Not a fit: Patients with metastatic disease considered incurable by local therapies or those who have previously undergone surgery for the tumor may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment strategies for patients with rectal and esophageal cancer.
How similar studies have performed: While the approach of monitoring PD-L1 expression using PET imaging is innovative, similar studies have shown promise in understanding tumor dynamics and treatment responses.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Vienna
- Medical University of Vienna — Vienna, Austria (Recruiting)
Study contacts
- Principal investigator: Alexander Haug, MD — Division of Nuclear Medicine, Department of Biomedical Imaging and Image-guided Therapy, Medical University of Vienna
- Study coordinator: Johannes Laengle, MD, PhD
- Email: johannes.laengle@meduniwien.ac.at
- Phone: +43140400 69260
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.