Actively Recruiting
PD-L1 PET Imaging During Neoadjuvant (Chemo)Radiotherapy in Esophageal and Rectal Cancer
Led by Johannes Laengle, MD, PhD · Updated on 2024-03-15
20
Participants Needed
1
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PD-L1 PET Imaging During Neoadjuvant (Chemo)Radiotherapy in Esophageal and Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Metastatic disease considered incurable by local therapies (except oligometastatic disease with curative intent)
- 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 participation in immunotherapy clinical studies
- Disagreement to use contraception during study and for 180 days after last dose if of reproductive potential
- Hepatitis B or C infection
- Human immunodeficiency virus (HIV) infection
- Immunodeficiency
- Allogeneic tissue or solid organ transplantation
- Autoimmune disease requiring systemic therapy in past 2 years
- Active non-infectious pneumonitis
- Active infection requiring systemic therapy
- Systemic steroids or immunosuppressive therapy within 7 days before study treatment
- Additional malignancy diagnosed or treated within 5 years (except certain skin and cervical/breast cancers)
- Use of botanical or herbal supplements for disease treatment within 2 weeks before treatment
- Serious or uncontrolled medical disorders
- Uncontrolled or significant cardiovascular disease
- Allergies or hypersensitivity to study drug components or chemotherapy drugs
- Prisoners or involuntarily incarcerated individuals
- Compulsory detention for psychiatric or physical illness
AI-Screening
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Trial Site Locations
Total: 1 location
1
Medical University of Vienna
Vienna, Austria, 1090
Actively Recruiting
Research Team
J
Johannes Laengle, MD, PhD
CONTACT
M
Michael Bergmann, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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