PD-L1 PET Imaging During Neoadjuvant (Chemo)Radiotherapy in Esophageal and Rectal Cancer
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
Johannes Laengle, MD, PhD
20 participants
Nov 1, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria18
- 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)
Interventions
50 Gy in 2 Gy fractions over 25 working days + capecitabine 1650 mg/m2/d PO
25 Gy in 5 Gy fractions over 5 working days
41.4 Gy in 1.8 Gy fractions over 23 working days + carboplatin AUC of 2 mg/ml/min + paclitaxel 50 mg/m2 IV Q1W
10 mg atezolizumab IV followed by 37 MBq 89Zr-atezolizumab IV. PET imaging will be done before neoadjuvant CRT/SCPRT (day 0) and between day 10-14 during CRT/SCPRT.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04564482